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