ID

39347

Descrição

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Palavras-chave

  1. 27/12/2019 27/12/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

27 de dezembro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

  1. StudyEvent: ODM
    1. Screen
Date of Visit
Descrição

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of visit/assessment
Descrição

Date of visit, Assessment Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Which cohort has subject been randomised to?
Descrição

Randomization, Cohort

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0599755
Demography
Descrição

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Descrição

Patient date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Sex
Descrição

Gender

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Descrição

Ethnic group

Tipo de dados

text

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Descrição

Your ancestry or national origin

Tipo de dados

text

Alias
UMLS CUI [1]
C3841890
VS Semi-supine
Descrição

VS Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
Actual date/time
Descrição

Vital signs, Semi-erect, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Height
Descrição

Body Height

Tipo de dados

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descrição

Body Weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Descrição

Body mass index

Tipo de dados

float

Unidades de medida
  • kg / m2
Alias
UMLS CUI [1]
C1305855
kg / m2
Blood pressure - Systolic
Descrição

Systolic Pressure, Semi-erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Blood pressure - Diastolic
Descrição

Diastolic blood pressure, Semi-erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart rate
Descrição

Heart rate, Semi-erect

Tipo de dados

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
bpm
VS Standing
Descrição

VS Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
Actual date/time
Descrição

Vital signs, Erect, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Height
Descrição

Body Height

Tipo de dados

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descrição

Body Weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Descrição

Body mass index

Tipo de dados

float

Unidades de medida
  • kg / m2
Alias
UMLS CUI [1]
C1305855
kg / m2
Blood pressure - Systolic
Descrição

Systolic Pressure, Erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
mm[Hg]
Blood pressure - Diastolic
Descrição

Diastolic blood pressure, Erect

Tipo de dados

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
mm[Hg]
Heart rate
Descrição

Heart rate, Erect

Tipo de dados

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
bpm
12-Lead ECG
Descrição

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Descrição

12 lead ECG, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Heart rate
Descrição

12 lead ECG, Heart rate

Tipo de dados

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Descrição

12 lead ECG, PR interval

Tipo de dados

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Descrição

12 lead ECG, QRS complex duration

Tipo de dados

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Descrição

12 lead ECG, QT Interval

Tipo de dados

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
Method of QTc Calculation
Descrição

12 lead ECG, Electrocardiogram QT corrected interval, Evaluation Method

Tipo de dados

text

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C2911685
Result of the ECG
Descrição

12 lead ECG, Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Eligibility Question
Descrição

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Descrição

Eligibility Determination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Male or female between the ages of 18 and 64, inclusive, at the time of signing the informed consent.
Descrição

Gender; Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
A female subject is eligible to participate of she is of non-childbearing potential - see protocol for definition of non-childbearing potential.
Descrição

Childbearing Potential

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 months after the final dose.
Descrição

Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
Healthy as determined by a responsible and experienced physician, based on a medical valuation including medical history, physical examination, laboratory tests and cardiac monitoring.
Descrição

Health Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018759
Body mass index 19 - 29.9 kg/m2 (inclusive), body weight >50 kg for males and >45 kg for females, who are not morbidly obese.
Descrição

Body mass index; Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Descrição

Informed Consent; Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
Descrição

English Language

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376245
Subjects must have AST, ALT, alkaline phosphatase and bilirubin <1.5xULN
Descrição

Aspartate aminotransferase measurement; Alanine aminotransferase measurement; Alkaline phosphatase measurement; Bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0344395
Subjects must have QTc values within the normal range, i.e. QTcF < 450 msec.
Descrição

QTc interval

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0489625
Subjects must have normal vital signs in standing and semi-supine position. Guideline normal ranges are systolic BP 90-140, diastolic BP 60-90, heart rate 50-90.
Descrição

Vital signs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518766
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Current or past diagnosis of psychiatric disorder, as assessed by the MINI.
Descrição

Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
Descrição

At risk for suicide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0563664
Current of past diagnosis of cardiovascular disease including but not limited to hypertension, cardiac arrhythmias and/or risk factors for coronary artery disease.
Descrição

Cardiovascular Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
Personal or family history of long QT syndrome, cardiac conduction disorder or other clinically significant cardiac disease.
Descrição

Long QT Syndrome; Cardiac conduction abnormality; Heart Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C1842820
UMLS CUI [3]
C0018799
Current or past diagnosis of a cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms).
Descrição

Cerebrovascular Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007820
Current or past diagnosis of autonomic dysfunction (e.g. prone to fainting, orthostatic hypotension, sinus arrhythmia).
Descrição

Autonomic nervous system, Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004388
UMLS CUI [1,2]
C3887504
Current or past diagnosis of acute or chronic respiratory disease (including asthma and chronic obstructive pulmonary disease)
Descrição

Respiration Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035204
Current or past diagnosis of acute or chronic renal disease.
Descrição

Kidney Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
Subjects with renal monitoring test values outside of the ranges in Appendix 3. Renal monitoring tests may be repeated once if value(s) are abnormal but such abnormality must have normalized by the baseline visit.
Descrição

Laboratory Procedures, Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
Subjects with a history of gastrointestinal bleeding and/or a history of peptic ulcer disease and/or presence of active gastrointestinal disease.
Descrição

Gastrointestinal Hemorrhage; Peptic Ulcer; Gastrointestinal Diseases, Active

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0030920
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0205177
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Descrição

Liver diseases; Abnormality of the liver; Biliary tract abnormality

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C4021780
UMLS CUI [3]
C0549613
Subjects with an unstable medical disorder or a disorder (including surgical interventions) that would likely interfere with the action, absorption, distribution, metabolism or excretion of GSK1034702, may pose a safety concern, or interfere with accurate assessment of safety.
Descrição

Disease, Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Descrição

Hepatitis B surface antigen positive; Hepatitis C antibody positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
A positive test for HIV antibody.
Descrição

HIV antibody positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920548
Drug or alcohol abuse within the 12 months prior to dosing.
Descrição

Drug abuse; Alcohol abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
A positive pre-study drug/alcohol screen.
Descrição

Drug screen (procedure); Blood alcohol test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373483
UMLS CUI [2]
C0948726
History of regular alcohol consumption within 6 months of the study defined as: • an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
Descrição

Alcohol consumption

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001948
Subject is a smoker.
Descrição

Tobacco use

Tipo de dados

text

Alias
UMLS CUI [1]
C0543414
Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John’s Wort) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Descrição

Pharmaceutical Preparations

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013227
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
Descrição

Red wine; Citrus aurantium; Grapefruit (food); GRAPEFRUIT JUICE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0349371
UMLS CUI [2]
C0330922
UMLS CUI [3]
C0995150
UMLS CUI [4]
C0452456
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Descrição

Experimental drug, Hypersensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
Hypersensitivity to any of the ingredients of dextromethorphan.
Descrição

Dextromethorphan, Hypersensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011816
UMLS CUI [1,2]
C0020517
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Descrição

Pharmaceutical Preparations, New

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205314
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Descrição

Blood Donation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005794
Unwillingness or inability to follow the procedures outlined in the protocol.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
Subject is mentally or legally incapacitated.
Descrição

Mental handicap; legal capacity, Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
Subject Identification
Descrição

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Descrição

Clinical Trial Subject Unique Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Randomisation Number
Descrição

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Descrição

Randomization, Possible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0332149
Yes, provide Randomisation number
Descrição

Randomization, Numbers

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Yes, provide Date of randomisation
Descrição

Randomization, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Holter
Descrição

Holter

Alias
UMLS CUI-1
C0013801
Start Date and Time of Holter
Descrição

Holter Electrocardiography, Start Date, Start time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Stop Date and Time of Holter
Descrição

Holter Electrocardiography, End Date, End Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Interpretation of Holter
Descrição

Holter Electrocardiography, Clinical Interpretation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C4086187
Summary Holter Abnormalities
Descrição

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C1704258
Record clinically significant abnormalities below - Check all that apply
Descrição

Holter Electrocardiography, Abnormality

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1704258
Electronically Transferred Lab Data
Descrição

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Haematology Date and time sample taken
Descrição

Hematology finding, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Hematology finding, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Descrição

Chemistry, Clinical, Sampling, Date in time, Time

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry Date and time sample taken
Descrição

Chemistry, Clinical, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Chemistry, Clinical, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Descrição

Urinalysis, Sampling, Date in time, Time

Tipo de dados

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Not Done
Descrição

Urinalysis, Sampling, Not Done

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696

Similar models

  1. StudyEvent: ODM
    1. Screen
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Which cohort has subject been randomised to?
text
C0034656 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
Code List
Which cohort has subject been randomised to?
CL Item
Cohort 1 - 14 day repeat dose (1)
CL Item
Cohort 2 - Single dose followed by 14 day repeat dose (2)
CL Item
Cohort 3 - 28 day repeat dose (3)
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (1)
CL Item
Female - Post-menopausal (2)
CL Item
Female - Sterile (of child-bearing age) (3)
CL Item
Female - Potentially able to bear children (4)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic ancestry
text
C3841890 (UMLS CUI [1])
Code List
Geographic ancestry
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Heritage (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
VS Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
Vital signs, Semi-erect, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Pressure, Semi-erect
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic blood pressure, Semi-erect
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart rate, Semi-erect
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Item Group
VS Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
Vital signs, Erect, Date in time, Time
Item
Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic Pressure, Erect
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Diastolic blood pressure, Erect
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Heart rate, Erect
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time, Time
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
12 lead ECG, PR interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT Interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
CL Item
Machine - QTcB(Bazett) (1)
CL Item
Machine - QTcF (Fridericia) (2)
CL Item
Manual (3)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender; Age
Item
Male or female between the ages of 18 and 64, inclusive, at the time of signing the informed consent.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Childbearing Potential
Item
A female subject is eligible to participate of she is of non-childbearing potential - see protocol for definition of non-childbearing potential.
boolean
C3831118 (UMLS CUI [1])
Contraceptive methods
Item
Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 months after the final dose.
boolean
C0700589 (UMLS CUI [1])
Health Status
Item
Healthy as determined by a responsible and experienced physician, based on a medical valuation including medical history, physical examination, laboratory tests and cardiac monitoring.
boolean
C0018759 (UMLS CUI [1])
Body mass index; Body Weight
Item
Body mass index 19 - 29.9 kg/m2 (inclusive), body weight >50 kg for males and >45 kg for females, who are not morbidly obese.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Informed Consent; Protocol Compliance
Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
English Language
Item
Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
boolean
C0376245 (UMLS CUI [1])
Aspartate aminotransferase measurement; Alanine aminotransferase measurement; Alkaline phosphatase measurement; Bilirubin measurement
Item
Subjects must have AST, ALT, alkaline phosphatase and bilirubin <1.5xULN
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0344395 (UMLS CUI [4])
QTc interval
Item
Subjects must have QTc values within the normal range, i.e. QTcF < 450 msec.
boolean
C0489625 (UMLS CUI [1])
Vital signs
Item
Subjects must have normal vital signs in standing and semi-supine position. Guideline normal ranges are systolic BP 90-140, diastolic BP 60-90, heart rate 50-90.
boolean
C0518766 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Mental disorders
Item
Current or past diagnosis of psychiatric disorder, as assessed by the MINI.
boolean
C0004936 (UMLS CUI [1])
At risk for suicide
Item
Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
boolean
C0563664 (UMLS CUI [1])
Cardiovascular Diseases
Item
Current of past diagnosis of cardiovascular disease including but not limited to hypertension, cardiac arrhythmias and/or risk factors for coronary artery disease.
boolean
C0007222 (UMLS CUI [1])
Long QT Syndrome; Cardiac conduction abnormality; Heart Diseases
Item
Personal or family history of long QT syndrome, cardiac conduction disorder or other clinically significant cardiac disease.
boolean
C0023976 (UMLS CUI [1])
C1842820 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
Cerebrovascular Disorders
Item
Current or past diagnosis of a cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms).
boolean
C0007820 (UMLS CUI [1])
Autonomic nervous system, Dysfunction
Item
Current or past diagnosis of autonomic dysfunction (e.g. prone to fainting, orthostatic hypotension, sinus arrhythmia).
boolean
C0004388 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
Respiration Disorders
Item
Current or past diagnosis of acute or chronic respiratory disease (including asthma and chronic obstructive pulmonary disease)
boolean
C0035204 (UMLS CUI [1])
Kidney Diseases
Item
Current or past diagnosis of acute or chronic renal disease.
boolean
C0022658 (UMLS CUI [1])
Laboratory Procedures, Renal function
Item
Subjects with renal monitoring test values outside of the ranges in Appendix 3. Renal monitoring tests may be repeated once if value(s) are abnormal but such abnormality must have normalized by the baseline visit.
boolean
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
Gastrointestinal Hemorrhage; Peptic Ulcer; Gastrointestinal Diseases, Active
Item
Subjects with a history of gastrointestinal bleeding and/or a history of peptic ulcer disease and/or presence of active gastrointestinal disease.
boolean
C0017181 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
Liver diseases; Abnormality of the liver; Biliary tract abnormality
Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
boolean
C0023895 (UMLS CUI [1])
C4021780 (UMLS CUI [2])
C0549613 (UMLS CUI [3])
Disease, Study Subject Participation Status
Item
Subjects with an unstable medical disorder or a disorder (including surgical interventions) that would likely interfere with the action, absorption, distribution, metabolism or excretion of GSK1034702, may pose a safety concern, or interfere with accurate assessment of safety.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Hepatitis B surface antigen positive; Hepatitis C antibody positive
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
HIV antibody positive
Item
A positive test for HIV antibody.
boolean
C0920548 (UMLS CUI [1])
Drug abuse; Alcohol abuse
Item
Drug or alcohol abuse within the 12 months prior to dosing.
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Drug screen (procedure); Blood alcohol test positive
Item
A positive pre-study drug/alcohol screen.
boolean
C0373483 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
Alcohol consumption
Item
History of regular alcohol consumption within 6 months of the study defined as: • an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
boolean
C0001948 (UMLS CUI [1])
Tobacco use
Item
Subject is a smoker.
text
C0543414 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John’s Wort) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
boolean
C0013227 (UMLS CUI [1])
Red wine; Citrus aurantium; Grapefruit (food); GRAPEFRUIT JUICE
Item
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
boolean
C0349371 (UMLS CUI [1])
C0330922 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
C0452456 (UMLS CUI [4])
Experimental drug, Hypersensitivity
Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Dextromethorphan, Hypersensitivity
Item
Hypersensitivity to any of the ingredients of dextromethorphan.
boolean
C0011816 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Study Subject Participation Status
Item
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
boolean
C2348568 (UMLS CUI [1])
Pharmaceutical Preparations, New
Item
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
boolean
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
Blood Donation
Item
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
boolean
C0005794 (UMLS CUI [1])
Protocol Compliance
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0525058 (UMLS CUI [1])
Mental handicap; legal capacity, Lacking
Item
Subject is mentally or legally incapacitated.
boolean
C1306341 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomization, Possible
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Randomization, Numbers
Item
Yes, provide Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomization, Date in time
Item
Yes, provide Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Holter
C0013801 (UMLS CUI-1)
Holter Electrocardiography, Start Date, Start time
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Holter Electrocardiography, End Date, End Time
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item
Record clinically significant abnormalities below - Check all that apply
text
C0013801 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Record clinically significant abnormalities below - Check all that apply
CL Item
No abnormalities (1)
CL Item
Sinus bradycardia (50-59 beats/min) (2)
CL Item
Sinus bradycardia (40-49 beats/min) (3)
CL Item
Sinus bradycardia (30-39 beats/min) (4)
CL Item
Sinus bradycardia (<30 beats/min) (5)
CL Item
Sinus pause (6)
CL Item
Sinus tachycardia (>100 beats/min) (7)
CL Item
Ectopic supraventricular beats (8)
CL Item
Ectopic supraventricular rhythm (9)
CL Item
Wandering atrial pacemaker (10)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (11)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (12)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (13)
CL Item
Atrial flutter (14)
CL Item
Atrial fibrillation (15)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (16)
CL Item
Junctional tachycardia (>100 beats/min) (17)
CL Item
Ventricular premature deplorisation (18)
CL Item
Ventricular couplets (19)
CL Item
Bigeminy (20)
CL Item
Trigeminy (21)
CL Item
Electrical alternans (22)
CL Item
R on T phenomenon (23)
CL Item
Ventricular fibrillation (24)
CL Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (25)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (26)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (27)
CL Item
Wide QRS tachycardia (diagnosis unknown (28)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (29)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (30)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (31)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (32)
CL Item
Torsades de Pointes (TdP) (33)
CL Item
Pacemaker (34)
CL Item
First degree AV block (PR interval >200msec) (35)
CL Item
Short PR Intervak (36)
CL Item
Second degree AV block (Mobitz type 1) (37)
CL Item
Second degree AV block (Mobitz type 2) (38)
CL Item
2:1 AV block (39)
CL Item
Third degree AV block (40)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (41)
CL Item
Right axis deviation (QRS axis more positive than +100 degrees) (42)
CL Item
Incomplete left bundle branch block (43)
CL Item
Incomplete left bundle branch block (44)
CL Item
Right bundle branch block (45)
CL Item
Left anterior hemiblock (46)
CL Item
Left posterior hemiblock (47)
CL Item
Left bundle branch block (48)
CL Item
Bifascicular block (49)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (50)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine (51)
CL Item
QTc prolongation >=500 msec (52)
CL Item
AV dissociation (53)
CL Item
Myocardial infarction, old (54)
CL Item
Myocardial infarction, non Q-wave (55)
CL Item
Non-specific ST-T changes (56)
CL Item
J point elevation (57)
CL Item
ST elevation (58)
CL Item
ST depression (59)
CL Item
ST segment abnormality (60)
CL Item
U waves (61)
CL Item
T wave inversion (62)
CL Item
T wave peaked (63)
CL Item
T waves biphasic (64)
CL Item
T waves flat (65)
CL Item
66)Notched T-waves (66)Notched T-waves)
CL Item
Low QRS voltage (67)
CL Item
T wave abnormality (68)
CL Item
Other abnormal rhythm (69)
CL Item
Other morphology (70)
CL Item
Other conduction (71)
CL Item
Other myocardial infarction (72)
CL Item
Other depolarization/repolarisation (73)
CL Item
Other abnormality/Cardiologist comments (74)
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Hematology finding, Sampling, Date in time, Time
Item
Haematology Date and time sample taken
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hematology finding, Sampling, Not Done
Item
Not Done
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Clinical Chemistry Date and time sample taken
text
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Code List
Clinical Chemistry Date and time sample taken
CL Item
Same as the Haematology sample (1)
Chemistry, Clinical, Sampling, Date in time, Time
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Chemistry, Clinical, Sampling, Not Done
Item
Not Done
boolean
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis, Sampling, Date in time, Time
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Urinalysis, Sampling, Not Done
Item
Not Done
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

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