ID
36790
Beschrijving
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
Trefwoorden
Versies (1)
- 09-06-19 09-06-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 juni 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503
Screening - Inclusion and Exclusion Criteria
- StudyEvent: ODM
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Healthy | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography | Abnormality | risk factors
Datatype
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
Beschrijving
Male aged 18 to 55 years inclusive at the screening visit.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Beschrijving
Body weight 350 kg and BMI within the range of 19-29 kglm2, inclusive.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Beschrijving
Absence of any mental illness as confirmed by administering SCID-I.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004936
- UMLS CUI [2]
- C0220952
Beschrijving
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2698977
- UMLS CUI [2]
- C0525058
Beschrijving
Confirmation of good blood circulation and patency of both radial and ulnar arteries in the hand by Allen’s test.
Datatype
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
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Drug screen positive; Blood alcohol test positive | Amphetamines | Barbiturates | Cocaine | Opiates | Cannabinoids | Benzodiazepines
Datatype
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
Beschrijving
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
Beschrijving
A positive test for HIV antibody.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0920548
Beschrijving
qtc interval | Gender | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0489625
- UMLS CUI [2]
- C0079399
- UMLS CUI [3]
- C0429087
- UMLS CUI [4]
- C1287082
- UMLS CUI [5]
- C0438167
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C1821417
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
Beschrijving
The subject has a significant cardiac disease or cardiac conduction disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018799
- UMLS CUI [2]
- C0264886
Beschrijving
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
Datatype
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
Beschrijving
The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877359
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0740482
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
Beschrijving
Alcohol consumption; Weekly | Alcohol consumption; Daily
Datatype
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
Beschrijving
Study Subject Participation Status
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0304229
Beschrijving
Exposure to more than four new chemical entities within 12 months priorto the first dosing day.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0449788
Beschrijving
Prescription Drugs | Drugs, Non-Prescription | Vitamins | Herbal medicine (product) | Dietary Supplements | patient safety
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0005794
Beschrijving
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
Datatype
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
Beschrijving
Unwillingness or inability to follow the procedures outlined in the protocol
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
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.
Datatype
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
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0034538
- UMLS CUI [2]
- C2348568
- UMLS CUI [3]
- C0032743
Beschrijving
Needle phobia or fear of arterial blood sampling
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0349231
- UMLS CUI [1,2]
- C1533685
- UMLS CUI [1,3]
- C0522183
Beschrijving
History of bleeding disorder or currently taking medication that affects blood clotting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005779
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0392760
- UMLS CUI [2,3]
- C0005778
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008909
- UMLS CUI [2]
- C0560840
- UMLS CUI [3]
- C0032743
Beschrijving
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
Datatype
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
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030163
- UMLS CUI [2]
- C0025080
- UMLS CUI [3]
- C0016542
- UMLS CUI [4,1]
- C0024485
- UMLS CUI [4,2]
- C0034394
Similar models
Screening - Inclusion and Exclusion Criteria
- StudyEvent: ODM
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C1704258 (UMLS CUI [6])
C0035648 (UMLS CUI [7])
C0001779 (UMLS CUI [2])
C1305855 (UMLS CUI [2])
C0220952 (UMLS CUI [2])
C2698977 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0042377 (UMLS CUI [2,1])
C0162857 (UMLS CUI [2,2])
C0042377 (UMLS CUI [3,1])
C0162858 (UMLS CUI [3,2])
C0231664 (UMLS CUI [4])
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])
C0281863 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
C0429087 (UMLS CUI [3])
C1287082 (UMLS CUI [4])
C0438167 (UMLS CUI [5])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0264886 (UMLS CUI [2])
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])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
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])
C0304229 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
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])
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])
C0005794 (UMLS CUI [2])
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])
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])
C0034538 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0032743 (UMLS CUI [3])
C1533685 (UMLS CUI [1,2])
C0522183 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005778 (UMLS CUI [2,3])
C0560840 (UMLS CUI [2])
C0032743 (UMLS CUI [3])
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])
C0025080 (UMLS CUI [2])
C0016542 (UMLS CUI [3])
C0024485 (UMLS CUI [4,1])
C0034394 (UMLS CUI [4,2])