ID
36790
Descripción
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
Palabras clave
Versiones (1)
- 9/6/19 9/6/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
9 de junio de 2019
DOI
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Licencia
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
Descripción
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
Healthy | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography | Abnormality | risk factors
Tipo de datos
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
Descripción
Male aged 18 to 55 years inclusive at the screening visit.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0001779
Descripción
Body weight 350 kg and BMI within the range of 19-29 kglm2, inclusive.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Descripción
Absence of any mental illness as confirmed by administering SCID-I.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0004936
- UMLS CUI [2]
- C0220952
Descripción
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2698977
- UMLS CUI [2]
- C0525058
Descripción
Confirmation of good blood circulation and patency of both radial and ulnar arteries in the hand by Allen’s test.
Tipo de datos
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
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Drug screen positive; Blood alcohol test positive | Amphetamines | Barbiturates | Cocaine | Opiates | Cannabinoids | Benzodiazepines
Tipo de datos
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
Descripción
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
Descripción
A positive test for HIV antibody.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0920548
Descripción
qtc interval | Gender | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0489625
- UMLS CUI [2]
- C0079399
- UMLS CUI [3]
- C0429087
- UMLS CUI [4]
- C1287082
- UMLS CUI [5]
- C0438167
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1821417
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
Descripción
The subject has a significant cardiac disease or cardiac conduction disorder
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0018799
- UMLS CUI [2]
- C0264886
Descripción
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
Tipo de datos
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
Descripción
The subject has liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0877359
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0740482
- UMLS CUI [2]
- C0871470
- UMLS CUI [3]
- C0428883
Descripción
Alcohol consumption; Weekly | Alcohol consumption; Daily
Tipo de datos
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
Descripción
Study Subject Participation Status
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0304229
Descripción
Exposure to more than four new chemical entities within 12 months priorto the first dosing day.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0449788
Descripción
Prescription Drugs | Drugs, Non-Prescription | Vitamins | Herbal medicine (product) | Dietary Supplements | patient safety
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2]
- C0005794
Descripción
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
Tipo de datos
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
Descripción
Unwillingness or inability to follow the procedures outlined in the protocol
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1321605
Descripción
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.
Tipo de datos
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
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0034538
- UMLS CUI [2]
- C2348568
- UMLS CUI [3]
- C0032743
Descripción
Needle phobia or fear of arterial blood sampling
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0349231
- UMLS CUI [1,2]
- C1533685
- UMLS CUI [1,3]
- C0522183
Descripción
History of bleeding disorder or currently taking medication that affects blood clotting
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005779
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0392760
- UMLS CUI [2,3]
- C0005778
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0008909
- UMLS CUI [2]
- C0560840
- UMLS CUI [3]
- C0032743
Descripción
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
Tipo de datos
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
Descripción
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
Tipo de datos
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])