ID

38953

Description

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Keywords

Versions (2)
  1. 11/13/19 11/13/19 -
  2. 11/15/19 11/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

English

Screening - Eligibility Criteria

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitoring.
Description

A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. However, • Subjects with cTpn I values above 99th percentile of normal range of the selected assay should always be excluded from enrollment; • Subjects with alkaline phosphatase or bilirubin >1.5xULN should always be excluded (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C0031831
UMLS CUI [3]
C0220825
UMLS CUI [4]
C0031809
UMLS CUI [5]
C4505426
UMLS CUI [6]
C0022885
UMLS CUI [7]
C0150496
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Description

Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
UMLS CUI [2]
C0021430
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
Description

Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
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 days post last dose (equivalent to 5 terminal half-lives post-last dose).
Description

Contraceptive methods; Date treatment or therapy started; Date last dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3173309
UMLS CUI [1,3]
C1762893
Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
History or presence of significant psychiatric neurological, musculo-skeletal , respiratory, gastrointestinal, hepatic, uncontrolled hypothyroidism, pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Description

Neuropsychiatric syndrome | Musculoskeletal System; Disease | Respiration Disorders | Gastrointestinal Diseases | Liver diseases | Hypothyroidism; Uncontrolled | Pancreatic Diseases | Kidney Diseases | Disease; Interferes with; Absorption, Physiological | Disease; Interferes with; Distribution | Disease; Interferes with; Metabolism | Disease; Interferes with; Excretory function

Data type

boolean

Alias
UMLS CUI [1]
C3203509
UMLS CUI [2,1]
C0026860
UMLS CUI [2,2]
C0012634
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0017178
UMLS CUI [5]
C0023895
UMLS CUI [6,1]
C0020676
UMLS CUI [6,2]
C0205318
UMLS CUI [7]
C0030286
UMLS CUI [8]
C0022658
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0237442
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C1704711
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0025519
UMLS CUI [12,1]
C0012634
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0221102
Subjects, who in the Investigator’s judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
Description

At risk for suicide | Suicidal behavior | Feeling suicidal (finding); C-SSRS Since Last Visit - Ideation With Plan/Intent

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C1760428
UMLS CUI [3,1]
C0424000
UMLS CUI [3,2]
C3641607
History of cardiovascular diseases and/or evidence of repolarization defects.
Description

History of cardiovascular diseases and/or evidence of repolarization defects.

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0948857
Family history of heriditary muscular disorders.
Description

Family history of heriditary muscular disorders.

Data type

boolean

Alias
UMLS CUI [1,1]
C0026848
UMLS CUI [1,2]
C0439660
Subjects with abnormal ECG defined as: average QTcB or QTcF > 450 msec; PQ < 120 ms or > 220 ms; complete left bundle branch block; second-or third-degree AV block; any relevant ST/T wave abnormalities ; any atrial or ventricular arrhtymias which are of clinical significance as determined by the Investigator.
Description

Electrocardiogram abnormal | QTcB - Bazett's Correction Formula | QTcF - Fridericia's Correction Formula | Electrocardiogram PQ interval | Left Bundle-Branch Block | Second degree atrioventricular block | EKG: T wave abnormal | EKG ST segment changes | Atrial Fibrillation; Atrial Flutter | Ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C1882512
UMLS CUI [3]
C1882513
UMLS CUI [4]
C1167690
UMLS CUI [5]
C0023211
UMLS CUI [6]
C0264906
UMLS CUI [7]
C0438167
UMLS CUI [8]
C0232326
UMLS CUI [9,1]
C0004238
UMLS CUI [9,2]
C0004239
UMLS CUI [10]
C0085612
History of regular alcohol consumption within 6 months of the study
Description

Defined as: • an average weekly intake of greater than 21 units (14 units for female) or an average daily intake of greater than 3 units (2 units for female). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
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.
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C1705248
UMLS CUI [3]
C0013182
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0205394
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
Description

Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.

Data type

boolean

Alias
UMLS CUI [1]
C0949366
UMLS CUI [2]
C1306341
UMLS CUI [3]
C0683673
UMLS CUI [4]
C0237167
UMLS CUI [5]
C0392337
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Description

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening

Data type

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0281863
A positive test for HIV antibody.
Description

A positive test for HIV antibody.

Data type

boolean

Alias
UMLS CUI [1]
C0920548
A positive pre-study drug/alcohol screen.
Description

A positive pre-study drug/alcohol screen.

Data type

boolean

Alias
UMLS CUI [1,1]
C0743295
UMLS CUI [1,2]
C1527048
UMLS CUI [2,1]
C0948726
UMLS CUI [2,2]
C1527048
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
Description

Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.

Data type

boolean

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C0543414
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) 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.
Description

Drugs, Non-Prescription; Prescription Drugs | Vitamins | Herbal Supplements | Dietary Supplements | ST. JOHN'S WORT EXTRACT | Enzymes; Inducer | Before; Administration of medication | Study; Procedure (set of actions) | patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0304227
UMLS CUI [2]
C0042890
UMLS CUI [3]
C1504473
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0813171
UMLS CUI [6,1]
C0014442
UMLS CUI [6,2]
C3898767
UMLS CUI [7,1]
C0332152
UMLS CUI [7,2]
C3469597
UMLS CUI [8,1]
C2603343
UMLS CUI [8,2]
C2700391
UMLS CUI [9]
C1113679
Consumption of broccoli, radish sprouts, cauliflower, cabbage, orange juice, apple juice, grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood sample.
Description

Broccoli - dietary | Radish (Vegetable) | Cauliflower (dietary) | Cabbage - dietary | Orange juice | Apple juice | GRAPEFRUIT JUICE | Grapefruit (food) | Before; Administration of medication | Collection of blood specimen for laboratory procedure; Pharmacokinetic aspects

Data type

boolean

Alias
UMLS CUI [1]
C0330499
UMLS CUI [2]
C0446300
UMLS CUI [3]
C0446302
UMLS CUI [4]
C0006619
UMLS CUI [5]
C0452458
UMLS CUI [6]
C0452454
UMLS CUI [7]
C0452456
UMLS CUI [8]
C0995150
UMLS CUI [9,1]
C0332152
UMLS CUI [9,2]
C3469597
UMLS CUI [10,1]
C0005834
UMLS CUI [10,2]
C0031328
The subject has participated in a clinical trial and has received an investigational product (IP) 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 IP (whichever is longer).
Description

Study Subject Participation Status | Experimental drug; Before; Administration of medication

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C3469597
Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
Description

Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0220806
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0205435
UMLS CUI [1,6]
C0439228
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Description

Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C0456388
Unwillingness or inability to follow the procedures outlined in the protocol.
Description

Unwillingness or inability to follow the procedures outlined in the protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C0525058
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
Description

The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1514989
UMLS CUI [2,2]
C3843422
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0220908
UMLS CUI [4]
C0589121
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
Description

Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C2732579
UMLS CUI [1,4]
C0035173
UMLS CUI [1,5]
C0080103
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Similar models

Screening - Eligibility Criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender; Healthy | Physicians | Evaluation | Physical Examination |Mini International Neuropsychiatric Interview | Laboratory Procedures | Cardiac monitoring
Item
Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitoring.
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0031831 (UMLS CUI [2])
C0220825 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C4505426 (UMLS CUI [5])
C0022885 (UMLS CUI [6])
C0150496 (UMLS CUI [7])
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Item
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
Item
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Contraceptive methods; Date treatment or therapy started; Date last dose
Item
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 days post last dose (equivalent to 5 terminal half-lives post-last dose).
boolean
C0700589 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Item
Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Neuropsychiatric syndrome | Musculoskeletal System; Disease | Respiration Disorders | Gastrointestinal Diseases | Liver diseases | Hypothyroidism; Uncontrolled | Pancreatic Diseases | Kidney Diseases | Disease; Interferes with; Absorption, Physiological | Disease; Interferes with; Distribution | Disease; Interferes with; Metabolism | Disease; Interferes with; Excretory function
Item
History or presence of significant psychiatric neurological, musculo-skeletal , respiratory, gastrointestinal, hepatic, uncontrolled hypothyroidism, pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
boolean
C3203509 (UMLS CUI [1])
C0026860 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0020676 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0030286 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0012634 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0237442 (UMLS CUI [9,3])
C0012634 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C1704711 (UMLS CUI [10,3])
C0012634 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0025519 (UMLS CUI [11,3])
C0012634 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0221102 (UMLS CUI [12,3])
At risk for suicide | Suicidal behavior | Feeling suicidal (finding); C-SSRS Since Last Visit - Ideation With Plan/Intent
Item
Subjects, who in the Investigator’s judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
boolean
C0563664 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
C0424000 (UMLS CUI [3,1])
C3641607 (UMLS CUI [3,2])
History of cardiovascular diseases and/or evidence of repolarization defects.
Item
History of cardiovascular diseases and/or evidence of repolarization defects.
boolean
C0007222 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
Family history of heriditary muscular disorders.
Item
Family history of heriditary muscular disorders.
boolean
C0026848 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
Electrocardiogram abnormal | QTcB - Bazett's Correction Formula | QTcF - Fridericia's Correction Formula | Electrocardiogram PQ interval | Left Bundle-Branch Block | Second degree atrioventricular block | EKG: T wave abnormal | EKG ST segment changes | Atrial Fibrillation; Atrial Flutter | Ventricular arrhythmia
Item
Subjects with abnormal ECG defined as: average QTcB or QTcF > 450 msec; PQ < 120 ms or > 220 ms; complete left bundle branch block; second-or third-degree AV block; any relevant ST/T wave abnormalities ; any atrial or ventricular arrhtymias which are of clinical significance as determined by the Investigator.
boolean
C0522055 (UMLS CUI [1])
C1882512 (UMLS CUI [2])
C1882513 (UMLS CUI [3])
C1167690 (UMLS CUI [4])
C0023211 (UMLS CUI [5])
C0264906 (UMLS CUI [6])
C0438167 (UMLS CUI [7])
C0232326 (UMLS CUI [8])
C0004238 (UMLS CUI [9,1])
C0004239 (UMLS CUI [9,2])
C0085612 (UMLS CUI [10])
History of regular alcohol consumption within 6 months of the study
Item
History of regular alcohol consumption within 6 months of the study
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
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.
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
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
Item
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
boolean
C0949366 (UMLS CUI [1])
C1306341 (UMLS CUI [2])
C0683673 (UMLS CUI [3])
C0237167 (UMLS CUI [4])
C0392337 (UMLS CUI [5])
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
boolean
C0019168 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
A positive test for HIV antibody.
Item
A positive test for HIV antibody.
boolean
C0920548 (UMLS CUI [1])
A positive pre-study drug/alcohol screen.
Item
A positive pre-study drug/alcohol screen.
boolean
C0743295 (UMLS CUI [1,1])
C1527048 (UMLS CUI [1,2])
C0948726 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
Item
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
boolean
C1697737 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])
Drugs, Non-Prescription; Prescription Drugs | Vitamins | Herbal Supplements | Dietary Supplements | ST. JOHN'S WORT EXTRACT | Enzymes; Inducer | Before; Administration of medication | Study; Procedure (set of actions) | patient safety
Item
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) 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
C0013231 (UMLS CUI [1,1])
C0304227 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
C0014442 (UMLS CUI [6,1])
C3898767 (UMLS CUI [6,2])
C0332152 (UMLS CUI [7,1])
C3469597 (UMLS CUI [7,2])
C2603343 (UMLS CUI [8,1])
C2700391 (UMLS CUI [8,2])
C1113679 (UMLS CUI [9])
Broccoli - dietary | Radish (Vegetable) | Cauliflower (dietary) | Cabbage - dietary | Orange juice | Apple juice | GRAPEFRUIT JUICE | Grapefruit (food) | Before; Administration of medication | Collection of blood specimen for laboratory procedure; Pharmacokinetic aspects
Item
Consumption of broccoli, radish sprouts, cauliflower, cabbage, orange juice, apple juice, grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood sample.
boolean
C0330499 (UMLS CUI [1])
C0446300 (UMLS CUI [2])
C0446302 (UMLS CUI [3])
C0006619 (UMLS CUI [4])
C0452458 (UMLS CUI [5])
C0452454 (UMLS CUI [6])
C0452456 (UMLS CUI [7])
C0995150 (UMLS CUI [8])
C0332152 (UMLS CUI [9,1])
C3469597 (UMLS CUI [9,2])
C0005834 (UMLS CUI [10,1])
C0031328 (UMLS CUI [10,2])
Study Subject Participation Status | Experimental drug; Before; Administration of medication
Item
The subject has participated in a clinical trial and has received an investigational product (IP) 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 IP (whichever is longer).
boolean
C2348568 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C3469597 (UMLS CUI [2,3])
Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
Item
Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
boolean
C0332157 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0439228 (UMLS CUI [1,6])
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
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])
C0456388 (UMLS CUI [2])
Unwillingness or inability to follow the procedures outlined in the protocol.
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
Item
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
boolean
C1514989 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1514989 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C0220908 (UMLS CUI [3,2])
C0589121 (UMLS CUI [4])
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
Item
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
boolean
C0027361 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0035173 (UMLS CUI [1,4])
C0080103 (UMLS CUI [1,5])
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