ID
38953
Beschrijving
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders
Trefwoorden
Versies (2)
- 13-11-19 13-11-19 -
- 15-11-19 15-11-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 november 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597
Screening - Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
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 and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. However, • Subjects with cTpn I values above 99th percentile of normal range of the selected assay should always be excluded from enrollment; • Subjects with alkaline phosphatase or bilirubin >1.5xULN should always be excluded (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0079399
- UMLS CUI [1,2]
- C3898900
- UMLS CUI [2]
- C0031831
- UMLS CUI [3]
- C0220825
- UMLS CUI [4]
- C0031809
- UMLS CUI [5]
- C4505426
- UMLS CUI [6]
- C0022885
- UMLS CUI [7]
- C0150496
Beschrijving
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0079399
- UMLS CUI [1,2]
- C0001779
- UMLS CUI [2]
- C0021430
Beschrijving
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Beschrijving
Contraceptive methods; Date treatment or therapy started; Date last dose
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C3173309
- UMLS CUI [1,3]
- C1762893
Beschrijving
Having given 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]
- C0525058
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Neuropsychiatric syndrome | Musculoskeletal System; Disease | Respiration Disorders | Gastrointestinal Diseases | Liver diseases | Hypothyroidism; Uncontrolled | Pancreatic Diseases | Kidney Diseases | Disease; Interferes with; Absorption, Physiological | Disease; Interferes with; Distribution | Disease; Interferes with; Metabolism | Disease; Interferes with; Excretory function
Datatype
boolean
Alias
- UMLS CUI [1]
- C3203509
- UMLS CUI [2,1]
- C0026860
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [3]
- C0035204
- UMLS CUI [4]
- C0017178
- UMLS CUI [5]
- C0023895
- UMLS CUI [6,1]
- C0020676
- UMLS CUI [6,2]
- C0205318
- UMLS CUI [7]
- C0030286
- UMLS CUI [8]
- C0022658
- UMLS CUI [9,1]
- C0012634
- UMLS CUI [9,2]
- C0521102
- UMLS CUI [9,3]
- C0237442
- UMLS CUI [10,1]
- C0012634
- UMLS CUI [10,2]
- C0521102
- UMLS CUI [10,3]
- C1704711
- UMLS CUI [11,1]
- C0012634
- UMLS CUI [11,2]
- C0521102
- UMLS CUI [11,3]
- C0025519
- UMLS CUI [12,1]
- C0012634
- UMLS CUI [12,2]
- C0521102
- UMLS CUI [12,3]
- C0221102
Beschrijving
At risk for suicide | Suicidal behavior | Feeling suicidal (finding); C-SSRS Since Last Visit - Ideation With Plan/Intent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0563664
- UMLS CUI [2]
- C1760428
- UMLS CUI [3,1]
- C0424000
- UMLS CUI [3,2]
- C3641607
Beschrijving
History of cardiovascular diseases and/or evidence of repolarization defects.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0007222
- UMLS CUI [2]
- C0948857
Beschrijving
Family history of heriditary muscular disorders.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0026848
- UMLS CUI [1,2]
- C0439660
Beschrijving
Electrocardiogram abnormal | QTcB - Bazett's Correction Formula | QTcF - Fridericia's Correction Formula | Electrocardiogram PQ interval | Left Bundle-Branch Block | Second degree atrioventricular block | EKG: T wave abnormal | EKG ST segment changes | Atrial Fibrillation; Atrial Flutter | Ventricular arrhythmia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0522055
- UMLS CUI [2]
- C1882512
- UMLS CUI [3]
- C1882513
- UMLS CUI [4]
- C1167690
- UMLS CUI [5]
- C0023211
- UMLS CUI [6]
- C0264906
- UMLS CUI [7]
- C0438167
- UMLS CUI [8]
- C0232326
- UMLS CUI [9,1]
- C0004238
- UMLS CUI [9,2]
- C0004239
- UMLS CUI [10]
- C0085612
Beschrijving
Defined as: • an average weekly intake of greater than 21 units (14 units for female) or an average daily intake of greater than 3 units (2 units for female). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
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 or GSK Medical Monitor, contraindicates their participation.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C1705248
- UMLS CUI [3]
- C0013182
- UMLS CUI [4,1]
- C0020517
- UMLS CUI [4,2]
- C0205394
Beschrijving
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0949366
- UMLS CUI [2]
- C1306341
- UMLS CUI [3]
- C0683673
- UMLS CUI [4]
- C0237167
- UMLS CUI [5]
- C0392337
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]
- C0019168
- UMLS CUI [2]
- C0281863
Beschrijving
A positive test for HIV antibody.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0920548
Beschrijving
A positive pre-study drug/alcohol screen.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0743295
- UMLS CUI [1,2]
- C1527048
- UMLS CUI [2,1]
- C0948726
- UMLS CUI [2,2]
- C1527048
Beschrijving
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C0543414
Beschrijving
Drugs, Non-Prescription; Prescription Drugs | Vitamins | Herbal Supplements | Dietary Supplements | ST. JOHN'S WORT EXTRACT | Enzymes; Inducer | Before; Administration of medication | Study; Procedure (set of actions) | patient safety
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013231
- UMLS CUI [1,2]
- C0304227
- UMLS CUI [2]
- C0042890
- UMLS CUI [3]
- C1504473
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0813171
- UMLS CUI [6,1]
- C0014442
- UMLS CUI [6,2]
- C3898767
- UMLS CUI [7,1]
- C0332152
- UMLS CUI [7,2]
- C3469597
- UMLS CUI [8,1]
- C2603343
- UMLS CUI [8,2]
- C2700391
- UMLS CUI [9]
- C1113679
Beschrijving
Broccoli - dietary | Radish (Vegetable) | Cauliflower (dietary) | Cabbage - dietary | Orange juice | Apple juice | GRAPEFRUIT JUICE | Grapefruit (food) | Before; Administration of medication | Collection of blood specimen for laboratory procedure; Pharmacokinetic aspects
Datatype
boolean
Alias
- UMLS CUI [1]
- C0330499
- UMLS CUI [2]
- C0446300
- UMLS CUI [3]
- C0446302
- UMLS CUI [4]
- C0006619
- UMLS CUI [5]
- C0452458
- UMLS CUI [6]
- C0452454
- UMLS CUI [7]
- C0452456
- UMLS CUI [8]
- C0995150
- UMLS CUI [9,1]
- C0332152
- UMLS CUI [9,2]
- C3469597
- UMLS CUI [10,1]
- C0005834
- UMLS CUI [10,2]
- C0031328
Beschrijving
Study Subject Participation Status | Experimental drug; Before; Administration of medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0332152
- UMLS CUI [2,3]
- C3469597
Beschrijving
Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0205314
- UMLS CUI [1,3]
- C0220806
- UMLS CUI [1,4]
- C0332152
- UMLS CUI [1,5]
- C0205435
- UMLS CUI [1,6]
- C0439228
Beschrijving
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005794
- UMLS CUI [2]
- C0456388
Beschrijving
Unwillingness or inability to follow the procedures outlined in the protocol.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [2,1]
- C1299582
- UMLS CUI [2,2]
- C0525058
Beschrijving
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514989
- UMLS CUI [1,2]
- C3843422
- UMLS CUI [1,3]
- C1299582
- UMLS CUI [2,1]
- C1514989
- UMLS CUI [2,2]
- C3843422
- UMLS CUI [2,3]
- C0558080
- UMLS CUI [3,1]
- C0332152
- UMLS CUI [3,2]
- C0220908
- UMLS CUI [4]
- C0589121
Beschrijving
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027361
- UMLS CUI [1,2]
- C1314939
- UMLS CUI [1,3]
- C2732579
- UMLS CUI [1,4]
- C0035173
- UMLS CUI [1,5]
- C0080103
Similar models
Screening - Eligibility Criteria
- StudyEvent: ODM
C3898900 (UMLS CUI [1,2])
C0031831 (UMLS CUI [2])
C0220825 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C4505426 (UMLS CUI [5])
C0022885 (UMLS CUI [6])
C0150496 (UMLS CUI [7])
C0001779 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C1305855 (UMLS CUI [2])
C3173309 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,2])
C0026860 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0020676 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0030286 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0012634 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0237442 (UMLS CUI [9,3])
C0012634 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C1704711 (UMLS CUI [10,3])
C0012634 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0025519 (UMLS CUI [11,3])
C0012634 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0221102 (UMLS CUI [12,3])
C1760428 (UMLS CUI [2])
C0424000 (UMLS CUI [3,1])
C3641607 (UMLS CUI [3,2])
C0948857 (UMLS CUI [2])
C0439660 (UMLS CUI [1,2])
C1882512 (UMLS CUI [2])
C1882513 (UMLS CUI [3])
C1167690 (UMLS CUI [4])
C0023211 (UMLS CUI [5])
C0264906 (UMLS CUI [6])
C0438167 (UMLS CUI [7])
C0232326 (UMLS CUI [8])
C0004238 (UMLS CUI [9,1])
C0004239 (UMLS CUI [9,2])
C0085612 (UMLS CUI [10])
C0205272 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C1306341 (UMLS CUI [2])
C0683673 (UMLS CUI [3])
C0237167 (UMLS CUI [4])
C0392337 (UMLS CUI [5])
C0281863 (UMLS CUI [2])
C1527048 (UMLS CUI [1,2])
C0948726 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
C0543414 (UMLS CUI [1,2])
C0304227 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
C0014442 (UMLS CUI [6,1])
C3898767 (UMLS CUI [6,2])
C0332152 (UMLS CUI [7,1])
C3469597 (UMLS CUI [7,2])
C2603343 (UMLS CUI [8,1])
C2700391 (UMLS CUI [8,2])
C1113679 (UMLS CUI [9])
C0446300 (UMLS CUI [2])
C0446302 (UMLS CUI [3])
C0006619 (UMLS CUI [4])
C0452458 (UMLS CUI [5])
C0452454 (UMLS CUI [6])
C0452456 (UMLS CUI [7])
C0995150 (UMLS CUI [8])
C0332152 (UMLS CUI [9,1])
C3469597 (UMLS CUI [9,2])
C0005834 (UMLS CUI [10,1])
C0031328 (UMLS CUI [10,2])
C0304229 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C3469597 (UMLS CUI [2,3])
C0205314 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0439228 (UMLS CUI [1,6])
C0456388 (UMLS CUI [2])
C0558080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C3843422 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1514989 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C0220908 (UMLS CUI [3,2])
C0589121 (UMLS CUI [4])
C1314939 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0035173 (UMLS CUI [1,4])
C0080103 (UMLS CUI [1,5])