ID

29966

Beskrivning

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Eligibility Question

Länk

https://clinicaltrials.gov/ct2/show/NCT01036061

Nyckelord

Versioner (1)
  1. 2018-04-30 2018-04-30 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 april 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

Engelsk

Eligibility Question

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility Question
Date of Visit
Beskrivning

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Beskrivning

Eligibility Question

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

If no, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Cirteria
Beskrivning

Inclusion Cirteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a significant clinical aboonnality or laboratory finding significantly 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 lo introduce additional risk factors and will not interfere with the study integrity.
Beskrivning

general health

Datatyp

boolean

Alias
UMLS CUI [1]
C0424575
UMLS CUI [2]
C1512693
AST, ALT, alkaline phosphatase and bilirubin =< I .5xULN (isolated bilirubin > I .5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Beskrivning

laboratory test finding

Datatyp

boolean

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C1512693
Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent. Males between 18 and 50 years of age inclusive, at the time of signing the informed consent will be eligible for the PET portion of the study.
Beskrivning

Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1512693
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 90 days after last dose.
Beskrivning

contraception male

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C1512693
A female subject is eligible to participate if she is: • Of child-bearing potential and agree to use one of the contraception methods listed in Section 8.1 Female subjects currently on oral, patch or depot honnonal contraception must agree to the additional contraceptive measures listed in Section 8.1 Female subjects must agree to use contraception ulllil 90 days after last dose.; • Of non-childbearing potential defined as pre-menopausal females with a documented tuba! ligation or hysterectomy; or postmenopausal defined as at least 12 consecutive months of spontaneous amenorrhea [In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ ml and estradiol < 40 pg/ml (< 140 pmol/L) is confinnatory.]. Females on honnone replacement therapy (HRT) and whose menopausal stan1s is in doubt will be required to use one of the contraception methods in Section 8.1.
Beskrivning

contraception female

Datatyp

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C1512693
Body weight=> 50 kg and BMI within the range 19.0 to 30.0 kg/m2 (inclusive).
Beskrivning

Body weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1512693
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1512693
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1516637
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Beskrivning

Hepatitis screen

Datatyp

boolean

Alias
UMLS CUI [1]
C1445958
UMLS CUI [2]
C0680251
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Beskrivning

liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0680251
The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
Beskrivning

heart disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0680251
Pulse rate <SO or > I 00 bpm OR a systolic blood pressure > 140 or <95 OR a diastolic blood pressure >90 or <50tnmHg at screening and/or baseline. These maybe repeated after discussion with the GSK medical monitor.
Beskrivning

Vital signs

Datatyp

text

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0680251
A screening ECG with a QTc (QTcB and/or QTcF) value of>450msec or a PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the Twave) at screening or baseline. These maybe repeated once after discussion with the GSK medical monitor.
Beskrivning

ECG finding

Datatyp

boolean

Alias
UMLS CUI [1]
C0438154
UMLS CUI [2]
C0680251
A positive pre-study drug/alcohol screen.
Beskrivning

drug/alcohol screen

Datatyp

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2]
C0948726
UMLS CUI [3]
C0680251
A positive test for HIV antibody.
Beskrivning

HIV test

Datatyp

boolean

Alias
UMLS CUI [1]
C1321876
UMLS CUI [2]
C0680251
History of regular alcohol consumption within 6 months of the study defined as: An average weekly i11take of>2 I units for males or > 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (- 240 ml) of beer, I glass (125 ml) of wine or I (25 ml) measure of spirits.
Beskrivning

alcohol consumption

Datatyp

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0680251
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 effoct of the investigational product (whichever is longer).
Beskrivning

investigational product

Datatyp

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C0680251
Exposure to more than four new chemical entities within 12 months prior to the first dosiug day.
Beskrivning

Exposure to more than four new chemical entities

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0680251
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days ( or 14 days if the drug is a potential enzyme inducer) or 5 hali~ 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 stl1dy procedures or compromise subject safety.
Beskrivning

Use of prescription or non-prescription drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0680251
History of sensitivity to any of the study medications, or components thereof or a bistory of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Beskrivning

Sensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0680251
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Beskrivning

blood donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C0680251
Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
Beskrivning

positive serum hCG test

Datatyp

boolean

Alias
UMLS CUI [1]
C0430060
UMLS CUI [2]
C0680251
Lactating females or those who were lactating in the month preceding enrolment.
Beskrivning

Lactating females

Datatyp

text

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0680251
Unwillingness or inability to follow the procedures outlined in the protocol.
Beskrivning

Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0680251
Subject is mentally or legally incapacitated.
Beskrivning

patient incapacitated

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0680251
Urinary nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Beskrivning

smoking

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0680251
Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication and throughout the duration of the study.
Beskrivning

Consumption of red wine or citrus fruits

Datatyp

boolean

Alias
UMLS CUI [1]
C0349371
UMLS CUI [2]
C0600183
UMLS CUI [3]
C0680251
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 any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
Beskrivning

suicide risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0680251
Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category lib or above i.e. No more than 10 rnSv in addition to the natural background radiation) in the previous 3 years u1cluding the dose from the study.
Beskrivning

The following apply to PET subjects only:

Datatyp

boolean

Alias
UMLS CUI [1]
C1517030
UMLS CUI [2]
C0680251
History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera for a period of 90 minutes.
Beskrivning

The following apply to PET subjects only:

Datatyp

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2]
C0680251
History of a neurological/psychiatric diagnosis (not limited to but including for example, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parku1sons disease, vascular dementia, transient ischemic attack, schizophrenia, majo r depressiou etc) that may influence the outcome or analysis of the scan results.
Beskrivning

The following apply to PET subjects only:

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0680251
Presence of a cardiac pacemaker or other electronic device or potential for ferromagnetic metal foreign bodies, such as staples, as assessed by a standard pre- MRI questionnaire.
Beskrivning

The following apply to PET subjects only:

Datatyp

text

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0025552
UMLS CUI [2]
C0680251
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Similar models

Eligibility Question

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Cirteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
general health
Item
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a significant clinical aboonnality or laboratory finding significantly 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 lo introduce additional risk factors and will not interfere with the study integrity.
boolean
C0424575 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
laboratory test finding
Item
AST, ALT, alkaline phosphatase and bilirubin =< I .5xULN (isolated bilirubin > I .5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
boolean
C0587081 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
Inclusion criteria
Item
Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent. Males between 18 and 50 years of age inclusive, at the time of signing the informed consent will be eligible for the PET portion of the study.
boolean
C0001779 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
contraception male
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 90 days after last dose.
boolean
C0700589 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
contraception female
Item
A female subject is eligible to participate if she is: • Of child-bearing potential and agree to use one of the contraception methods listed in Section 8.1 Female subjects currently on oral, patch or depot honnonal contraception must agree to the additional contraceptive measures listed in Section 8.1 Female subjects must agree to use contraception ulllil 90 days after last dose.; • Of non-childbearing potential defined as pre-menopausal females with a documented tuba! ligation or hysterectomy; or postmenopausal defined as at least 12 consecutive months of spontaneous amenorrhea [In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ ml and estradiol < 40 pg/ml (< 140 pmol/L) is confinnatory.]. Females on honnone replacement therapy (HRT) and whose menopausal stan1s is in doubt will be required to use one of the contraception methods in Section 8.1.
boolean
C0420837 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
Body weight
Item
Body weight=> 50 kg and BMI within the range 19.0 to 30.0 kg/m2 (inclusive).
boolean
C0005910 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
informed consent
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])
C1512693 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Hepatitis screen
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
boolean
C1445958 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
liver disease
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])
C0680251 (UMLS CUI [2])
heart disease
Item
The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
boolean
C0018799 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Vital signs
Item
Pulse rate <SO or > I 00 bpm OR a systolic blood pressure > 140 or <95 OR a diastolic blood pressure >90 or <50tnmHg at screening and/or baseline. These maybe repeated after discussion with the GSK medical monitor.
text
C0518766 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
ECG finding
Item
A screening ECG with a QTc (QTcB and/or QTcF) value of>450msec or a PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the Twave) at screening or baseline. These maybe repeated once after discussion with the GSK medical monitor.
boolean
C0438154 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
drug/alcohol screen
Item
A positive pre-study drug/alcohol screen.
boolean
C0743295 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
C0680251 (UMLS CUI [3])
HIV test
Item
A positive test for HIV antibody.
boolean
C1321876 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
alcohol consumption
Item
History of regular alcohol consumption within 6 months of the study defined as: An average weekly i11take of>2 I units for males or > 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (- 240 ml) of beer, I glass (125 ml) of wine or I (25 ml) measure of spirits.
boolean
C0001948 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
investigational product
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 effoct of the investigational product (whichever is longer).
boolean
C0304229 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Exposure to more than four new chemical entities
Item
Exposure to more than four new chemical entities within 12 months prior to the first dosiug day.
boolean
C0013227 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Use of prescription or non-prescription drugs
Item
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days ( or 14 days if the drug is a potential enzyme inducer) or 5 hali~ 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 stl1dy procedures or compromise subject safety.
boolean
C0013227 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Sensitivity
Item
History of sensitivity to any of the study medications, or components thereof or a bistory of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
boolean
C0020517 (UMLS CUI [1])
C0680251 (UMLS CUI [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])
C0680251 (UMLS CUI [2])
positive serum hCG test
Item
Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
boolean
C0430060 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Lactating females
Item
Lactating females or those who were lactating in the month preceding enrolment.
text
C2828358 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Compliance
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0525058 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
patient incapacitated
Item
Subject is mentally or legally incapacitated.
boolean
C1321605 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
smoking
Item
Urinary nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
boolean
C0543414 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Consumption of red wine or citrus fruits
Item
Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication and throughout the duration of the study.
boolean
C0349371 (UMLS CUI [1])
C0600183 (UMLS CUI [2])
C0680251 (UMLS CUI [3])
suicide risk
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 any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
boolean
C0563664 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
radiation burden
Item
Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category lib or above i.e. No more than 10 rnSv in addition to the natural background radiation) in the previous 3 years u1cluding the dose from the study.
boolean
C1517030 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
claustrophobia
Item
History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera for a period of 90 minutes.
boolean
C0008909 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
neurological/psychiatric diagnosis
Item
History of a neurological/psychiatric diagnosis (not limited to but including for example, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parku1sons disease, vascular dementia, transient ischemic attack, schizophrenia, majo r depressiou etc) that may influence the outcome or analysis of the scan results.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0680251 (UMLS CUI [3])
Exclusion Criteria
Item
Presence of a cardiac pacemaker or other electronic device or potential for ferromagnetic metal foreign bodies, such as staples, as assessed by a standard pre- MRI questionnaire.
text
C0021102 (UMLS CUI [1,1])
C0025552 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2])
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