ID

36790

Description

Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Keywords

Versions (1)
  1. 6/9/19 6/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 9, 2019

DOI

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License

Creative Commons BY-NC 3.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503

English

Screening - Inclusion and Exclusion Criteria

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Description

Eligibility Question

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

If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Healthy, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. 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 determines that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Description

Healthy | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography | Abnormality | risk factors

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0022885
UMLS CUI [5]
C1623258
UMLS CUI [6]
C1704258
UMLS CUI [7]
C0035648
2. Male aged 18 to 55 years inclusive at the screening visit.
Description

Male aged 18 to 55 years inclusive at the screening visit.

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. Body weight 350 kg and BMI within the range of 19-29 kglm2, inclusive.
Description

Body weight 350 kg and BMI within the range of 19-29 kglm2, inclusive.

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
4. Absence of any mental illness as confirmed by administering SCID-I.
Description

Absence of any mental illness as confirmed by administering SCID-I.

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0220952
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

Capable of giving 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]
C2698977
UMLS CUI [2]
C0525058
6. Confirmation of good blood circulation and patency of both radial and ulnar arteries in the hand by Allen’s test.
Description

Confirmation of good blood circulation and patency of both radial and ulnar arteries in the hand by Allen’s test.

Data type

boolean

Alias
UMLS CUI [1]
C0005775
UMLS CUI [2,1]
C0042377
UMLS CUI [2,2]
C0162857
UMLS CUI [3,1]
C0042377
UMLS CUI [3,2]
C0162858
UMLS CUI [4]
C0231664
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. The subject has a positive pre-study drug/ alcohol screen. Volunteer can be re-screened at the discretion of the investigator. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
Description

Drug screen positive; Blood alcohol test positive | Amphetamines | Barbiturates | Cocaine | Opiates | Cannabinoids | Benzodiazepines

Data type

boolean

Alias
UMLS CUI [1,1]
C0743295
UMLS CUI [1,2]
C0948726
UMLS CUI [2]
C0002667
UMLS CUI [3]
C0004745
UMLS CUI [4]
C0009170
UMLS CUI [5]
C0376196
UMLS CUI [6]
C0006864
UMLS CUI [7]
C0005064
2. 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]
C0149709
UMLS CUI [2]
C0281863
3. A positive test for HIV antibody.
Description

A positive test for HIV antibody.

Data type

boolean

Alias
UMLS CUI [1]
C0920548
4. QTc interval >430 ms for males, and/ 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 T-wave).
Description

qtc interval | Gender | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0489625
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0429087
UMLS CUI [4]
C1287082
UMLS CUI [5]
C0438167
5. The subject has a sustained resting pulse rate <40 or >90 bpm OR a systolic blood pressure >140 or <90 OR a diastolic blood pressure >90 or <50
Description

The subject has a sustained resting pulse rate <40 or >90 bpm OR a systolic blood pressure >140 or <90 OR a diastolic blood pressure >90 or <50

Data type

boolean

Alias
UMLS CUI [1]
C1821417
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
6. The subject has a significant cardiac disease or cardiac conduction disorder
Description

The subject has a significant cardiac disease or cardiac conduction disorder

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0264886
7. Consumption of poppy-seed-containing food, or any other food or drink containing quinine, grapefruit or grapefruit juice, red wine, Seville oranges, apple juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard), and charbroiled meats, from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood and or pharmacodynamic sample.
Description

Poppy seed (dietary); Food | Quinine | Grapefruit (food) | Red wine | Citrus aurantium | Apple juice | Vegetables | Meat | Drug Kinetics; Pharmacodynamics; Collection of blood specimen for laboratory procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0453264
UMLS CUI [1,2]
C0016452
UMLS CUI [2]
C0034417
UMLS CUI [3]
C0995150
UMLS CUI [4]
C0349371
UMLS CUI [5]
C0330922
UMLS CUI [6]
C0452454
UMLS CUI [7]
C0042440
UMLS CUI [8,1]
C0025017
UMLS CUI [8,2]
C0205435
UMLS CUI [9,1]
C3174092
UMLS CUI [9,2]
C0031327
UMLS CUI [9,3]
C0005834
UMLS CUI [10,1]
C0851347
UMLS CUI [10,2]
C0005834
8. The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT.
Description

The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT.

Data type

boolean

Alias
UMLS CUI [1]
C0877359
9. Current or past history of symptomatic orthostatic hypotension. The following drops in blood pressure at screening will exclude the volunteer: changes of greater than 20 mmHg systolic or 10 mmHg diastolic within 3 min of standing.
Description

Current or past history of symptomatic orthostatic hypotension. The following drops in blood pressure at screening will exclude the volunteer: changes ofgreater than 20 mm Hg systolic or 10 mm Hg diastolic within 3 min of standing.

Data type

boolean

Alias
UMLS CUI [1]
C0740482
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
10. History of regular alcohol consumption within 6 months of the study defined as: - An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spints or 1 glass (125mL) of wine.
Description

Alcohol consumption; Weekly | Alcohol consumption; Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0332174
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C0332173
11. 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).
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0304229
12. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Description

Exposure to more than four new chemical entities within 12 months priorto the first dosing day.

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0449788
13. 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 the medication will not interfere with the study procedures or compromise subject safety.
Description

Prescription Drugs | Drugs, Non-Prescription | Vitamins | Herbal medicine (product) | Dietary Supplements | patient safety

Data type

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0042890
UMLS CUI [4]
C2240391
UMLS CUI [5]
C0242295
UMLS CUI [6,1]
C3174092
UMLS CUI [6,2]
C0205435
UMLS CUI [7]
C1113679
14. 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 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 contraindicates their participation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0013182
UMLS CUI [3,3]
C0020517
15. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within the previous 56 day period.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0005794
16. An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of administration of GSK1018921 until 90 days following administration of GSK1018921;OR An unwillingness of the male subject to use a condom in addition to having their female partner use another form of contraception such as an IUD, spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of administration of study medication until 90 days following administration of study medication.
Description

Unwilling; abstaining from sex | Pregnancy; Breast Feeding | Unwilling; Condoms, Male; Use of | Contraceptive methods | Intrauterine Devices | Spermatocidal Agents | Contraceptives, Oral | Progesterone | Subdermal implantation of progesterone | Tubal Ligation | Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C1171321
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0006147
UMLS CUI [3,1]
C0558080
UMLS CUI [3,2]
C0009653
UMLS CUI [3,3]
C1524063
UMLS CUI [4,1]
C0558080
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0558080
UMLS CUI [5,2]
C0021900
UMLS CUI [6,1]
C0558080
UMLS CUI [6,2]
C0037862
UMLS CUI [7,1]
C0558080
UMLS CUI [7,2]
C0009905
UMLS CUI [8,1]
C0558080
UMLS CUI [8,2]
C0033308
UMLS CUI [9,1]
C0558080
UMLS CUI [9,2]
C0864560
UMLS CUI [10,1]
C0558080
UMLS CUI [10,2]
C0520483
UMLS CUI [11]
C0032961
17. 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]
C1321605
18. The subject has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Description

The subject has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0035078
UMLS CUI [4]
C2359476
UMLS CUI [5,1]
C0392760
UMLS CUI [5,2]
C0678745
UMLS CUI [6,1]
C0392760
UMLS CUI [6,2]
C0683140
UMLS CUI [7,1]
C0392760
UMLS CUI [7,2]
C0221102
19. History of exposure to ionising radiation due to participation in research studies in the previous 365 days, which when combined with exposure from all PET scans in this study will cause overall radiation exposure of more than 10 mSv.
Description

History of exposure to ionising radiation due to participation in research studies in the previous 365 days, which when combined with exposure from all PET scans in this study will cause overall radiation exposure of more than 10 mSv.

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0034538
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0032743
20. Needle phobia or fear of arterial blood sampling.
Description

Needle phobia or fear of arterial blood sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0349231
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0522183
21. History of bleeding disorder or currently taking medication that affects blood clotting
Description

History of bleeding disorder or currently taking medication that affects blood clotting

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005778
22. History of or suffers from claustrophobia or feels that they will be unable to lie still on their back in the PET camera for a period of at least 2 hours.
Description

History of or suffers from claustrophobia or feels that they will be unable to lie still on their back inthe PET camera for a period of at least 2 hours

Data type

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2]
C0560840
UMLS CUI [3]
C0032743
23. History or presence of neurological or psychiatric conditions (e.g., stroke, significant traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, any unexplained loss of consciousness, schizophrenia, major depression etc) that may influence the outcome or analysis of the scan results.
Description

nervous system disorder | Mental disorders | Cerebrovascular accident | Traumatic Brain Injury | Epilepsy | space-occupying lesion | Multiple Sclerosis | Parkinson Disease | Dementia, Vascular | Transient Ischemic Attack | Unconscious State; Unexplained | Schizophrenia | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0876926
UMLS CUI [5]
C0014544
UMLS CUI [6]
C0332562
UMLS CUI [7]
C0026769
UMLS CUI [8]
C0030567
UMLS CUI [9]
C0011269
UMLS CUI [10]
C0007787
UMLS CUI [11,1]
C0041657
UMLS CUI [11,2]
C4288071
UMLS CUI [12]
C0036341
UMLS CUI [13]
C1269683
24. Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire that contraindicates the MR performance
Description

Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire that contraindicates the MR performance

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0025080
UMLS CUI [3]
C0016542
UMLS CUI [4,1]
C0024485
UMLS CUI [4,2]
C0034394
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Similar models

Screening - Inclusion and Exclusion Criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
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)
Healthy | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography | Abnormality | risk factors
Item
1. Healthy, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. 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 determines that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
boolean
C3898900 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C1704258 (UMLS CUI [6])
C0035648 (UMLS CUI [7])
Male aged 18 to 55 years inclusive at the screening visit.
Item
2. Male aged 18 to 55 years inclusive at the screening visit.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body weight 350 kg and BMI within the range of 19-29 kglm2, inclusive.
Item
3. Body weight 350 kg and BMI within the range of 19-29 kglm2, inclusive.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Absence of any mental illness as confirmed by administering SCID-I.
Item
4. Absence of any mental illness as confirmed by administering SCID-I.
boolean
C0004936 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Item
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Confirmation of good blood circulation and patency of both radial and ulnar arteries in the hand by Allen’s test.
Item
6. Confirmation of good blood circulation and patency of both radial and ulnar arteries in the hand by Allen’s test.
boolean
C0005775 (UMLS CUI [1])
C0042377 (UMLS CUI [2,1])
C0162857 (UMLS CUI [2,2])
C0042377 (UMLS CUI [3,1])
C0162858 (UMLS CUI [3,2])
C0231664 (UMLS CUI [4])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Drug screen positive; Blood alcohol test positive | Amphetamines | Barbiturates | Cocaine | Opiates | Cannabinoids | Benzodiazepines
Item
1. The subject has a positive pre-study drug/ alcohol screen. Volunteer can be re-screened at the discretion of the investigator. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
boolean
C0743295 (UMLS CUI [1,1])
C0948726 (UMLS CUI [1,2])
C0002667 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0009170 (UMLS CUI [4])
C0376196 (UMLS CUI [5])
C0006864 (UMLS CUI [6])
C0005064 (UMLS CUI [7])
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Item
2. 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])
A positive test for HIV antibody.
Item
3. A positive test for HIV antibody.
boolean
C0920548 (UMLS CUI [1])
qtc interval | Gender | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal
Item
4. QTc interval >430 ms for males, and/ 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 T-wave).
boolean
C0489625 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0429087 (UMLS CUI [3])
C1287082 (UMLS CUI [4])
C0438167 (UMLS CUI [5])
The subject has a sustained resting pulse rate <40 or >90 bpm OR a systolic blood pressure >140 or <90 OR a diastolic blood pressure >90 or <50
Item
5. The subject has a sustained resting pulse rate <40 or >90 bpm OR a systolic blood pressure >140 or <90 OR a diastolic blood pressure >90 or <50
boolean
C1821417 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
The subject has a significant cardiac disease or cardiac conduction disorder
Item
6. The subject has a significant cardiac disease or cardiac conduction disorder
boolean
C0018799 (UMLS CUI [1])
C0264886 (UMLS CUI [2])
Poppy seed (dietary); Food | Quinine | Grapefruit (food) | Red wine | Citrus aurantium | Apple juice | Vegetables | Meat | Drug Kinetics; Pharmacodynamics; Collection of blood specimen for laboratory procedure
Item
7. Consumption of poppy-seed-containing food, or any other food or drink containing quinine, grapefruit or grapefruit juice, red wine, Seville oranges, apple juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard), and charbroiled meats, from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood and or pharmacodynamic sample.
boolean
C0453264 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
C0034417 (UMLS CUI [2])
C0995150 (UMLS CUI [3])
C0349371 (UMLS CUI [4])
C0330922 (UMLS CUI [5])
C0452454 (UMLS CUI [6])
C0042440 (UMLS CUI [7])
C0025017 (UMLS CUI [8,1])
C0205435 (UMLS CUI [8,2])
C3174092 (UMLS CUI [9,1])
C0031327 (UMLS CUI [9,2])
C0005834 (UMLS CUI [9,3])
C0851347 (UMLS CUI [10,1])
C0005834 (UMLS CUI [10,2])
The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT.
Item
8. The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT.
boolean
C0877359 (UMLS CUI [1])
Current or past history of symptomatic orthostatic hypotension. The following drops in blood pressure at screening will exclude the volunteer: changes ofgreater than 20 mm Hg systolic or 10 mm Hg diastolic within 3 min of standing.
Item
9. Current or past history of symptomatic orthostatic hypotension. The following drops in blood pressure at screening will exclude the volunteer: changes of greater than 20 mmHg systolic or 10 mmHg diastolic within 3 min of standing.
boolean
C0740482 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Alcohol consumption; Weekly | Alcohol consumption; Daily
Item
10. History of regular alcohol consumption within 6 months of the study defined as: - An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spints or 1 glass (125mL) of wine.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001948 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
C0001948 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
Study Subject Participation Status
Item
11. 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])
C0304229 (UMLS CUI [2])
Exposure to more than four new chemical entities within 12 months priorto the first dosing day.
Item
12. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
boolean
C0332157 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Prescription Drugs | Drugs, Non-Prescription | Vitamins | Herbal medicine (product) | Dietary Supplements | patient safety
Item
13. 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 the medication will not interfere with the study procedures or compromise subject safety.
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C2240391 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C3174092 (UMLS CUI [6,1])
C0205435 (UMLS CUI [6,2])
C1113679 (UMLS CUI [7])
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 contraindicates their participation.
Item
14. 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 contraindicates their participation.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0013182 (UMLS CUI [3,2])
C0020517 (UMLS CUI [3,3])
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within the previous 56 day period.
Item
15. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within the previous 56 day period.
boolean
C2348568 (UMLS CUI [1])
C0005794 (UMLS CUI [2])
Unwilling; abstaining from sex | Pregnancy; Breast Feeding | Unwilling; Condoms, Male; Use of | Contraceptive methods | Intrauterine Devices | Spermatocidal Agents | Contraceptives, Oral | Progesterone | Subdermal implantation of progesterone | Tubal Ligation | Pregnancy
Item
16. An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of administration of GSK1018921 until 90 days following administration of GSK1018921;OR An unwillingness of the male subject to use a condom in addition to having their female partner use another form of contraception such as an IUD, spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of administration of study medication until 90 days following administration of study medication.
boolean
C0558080 (UMLS CUI [1,1])
C1171321 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0558080 (UMLS CUI [3,1])
C0009653 (UMLS CUI [3,2])
C1524063 (UMLS CUI [3,3])
C0558080 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [5,1])
C0021900 (UMLS CUI [5,2])
C0558080 (UMLS CUI [6,1])
C0037862 (UMLS CUI [6,2])
C0558080 (UMLS CUI [7,1])
C0009905 (UMLS CUI [7,2])
C0558080 (UMLS CUI [8,1])
C0033308 (UMLS CUI [8,2])
C0558080 (UMLS CUI [9,1])
C0864560 (UMLS CUI [9,2])
C0558080 (UMLS CUI [10,1])
C0520483 (UMLS CUI [10,2])
C0032961 (UMLS CUI [11])
Unwillingness or inability to follow the procedures outlined in the protocol
Item
17. Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C1321605 (UMLS CUI [1])
The subject has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Item
18. The subject has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
boolean
C0017178 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C2359476 (UMLS CUI [4])
C0392760 (UMLS CUI [5,1])
C0678745 (UMLS CUI [5,2])
C0392760 (UMLS CUI [6,1])
C0683140 (UMLS CUI [6,2])
C0392760 (UMLS CUI [7,1])
C0221102 (UMLS CUI [7,2])
History of exposure to ionising radiation due to participation in research studies in the previous 365 days, which when combined with exposure from all PET scans in this study will cause overall radiation exposure of more than 10 mSv.
Item
19. History of exposure to ionising radiation due to participation in research studies in the previous 365 days, which when combined with exposure from all PET scans in this study will cause overall radiation exposure of more than 10 mSv.
boolean
C0332157 (UMLS CUI [1,1])
C0034538 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0032743 (UMLS CUI [3])
Needle phobia or fear of arterial blood sampling
Item
20. Needle phobia or fear of arterial blood sampling.
boolean
C0349231 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0522183 (UMLS CUI [1,3])
History of bleeding disorder or currently taking medication that affects blood clotting
Item
21. History of bleeding disorder or currently taking medication that affects blood clotting
boolean
C0005779 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005778 (UMLS CUI [2,3])
History of or suffers from claustrophobia or feels that they will be unable to lie still on their back inthe PET camera for a period of at least 2 hours
Item
22. History of or suffers from claustrophobia or feels that they will be unable to lie still on their back in the PET camera for a period of at least 2 hours.
boolean
C0008909 (UMLS CUI [1])
C0560840 (UMLS CUI [2])
C0032743 (UMLS CUI [3])
nervous system disorder | Mental disorders | Cerebrovascular accident | Traumatic Brain Injury | Epilepsy | space-occupying lesion | Multiple Sclerosis | Parkinson Disease | Dementia, Vascular | Transient Ischemic Attack | Unconscious State; Unexplained | Schizophrenia | Major Depressive Disorder
Item
23. History or presence of neurological or psychiatric conditions (e.g., stroke, significant traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, any unexplained loss of consciousness, schizophrenia, major depression etc) that may influence the outcome or analysis of the scan results.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0876926 (UMLS CUI [4])
C0014544 (UMLS CUI [5])
C0332562 (UMLS CUI [6])
C0026769 (UMLS CUI [7])
C0030567 (UMLS CUI [8])
C0011269 (UMLS CUI [9])
C0007787 (UMLS CUI [10])
C0041657 (UMLS CUI [11,1])
C4288071 (UMLS CUI [11,2])
C0036341 (UMLS CUI [12])
C1269683 (UMLS CUI [13])
Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire that contraindicates the MR performance
Item
24. Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire that contraindicates the MR performance
boolean
C0030163 (UMLS CUI [1])
C0025080 (UMLS CUI [2])
C0016542 (UMLS CUI [3])
C0024485 (UMLS CUI [4,1])
C0034394 (UMLS CUI [4,2])
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