ID
38953
Beskrivning
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
Nyckelord
Versioner (2)
- 2019-11-13 2019-11-13 -
- 2019-11-15 2019-11-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 november 2019
DOI
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Licens
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
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
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%);
Datatyp
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
Beskrivning
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0079399
- UMLS CUI [1,2]
- C0001779
- UMLS CUI [2]
- C0021430
Beskrivning
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Beskrivning
Contraceptive methods; Date treatment or therapy started; Date last dose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C3173309
- UMLS CUI [1,3]
- C1762893
Beskrivning
Having given 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]
- C0525058
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
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
Datatyp
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
Beskrivning
At risk for suicide | Suicidal behavior | Feeling suicidal (finding); C-SSRS Since Last Visit - Ideation With Plan/Intent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0563664
- UMLS CUI [2]
- C1760428
- UMLS CUI [3,1]
- C0424000
- UMLS CUI [3,2]
- C3641607
Beskrivning
History of cardiovascular diseases and/or evidence of repolarization defects.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0007222
- UMLS CUI [2]
- C0948857
Beskrivning
Family history of heriditary muscular disorders.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0026848
- UMLS CUI [1,2]
- C0439660
Beskrivning
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
Datatyp
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
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0205272
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 or GSK Medical Monitor, contraindicates their participation.
Datatyp
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
Beskrivning
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0949366
- UMLS CUI [2]
- C1306341
- UMLS CUI [3]
- C0683673
- UMLS CUI [4]
- C0237167
- UMLS CUI [5]
- C0392337
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]
- C0019168
- UMLS CUI [2]
- C0281863
Beskrivning
A positive test for HIV antibody.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0920548
Beskrivning
A positive pre-study drug/alcohol screen.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0743295
- UMLS CUI [1,2]
- C1527048
- UMLS CUI [2,1]
- C0948726
- UMLS CUI [2,2]
- C1527048
Beskrivning
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1697737
- UMLS CUI [1,2]
- C0543414
Beskrivning
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
Datatyp
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
Beskrivning
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
Datatyp
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
Beskrivning
Study Subject Participation Status | Experimental drug; Before; Administration of medication
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0332152
- UMLS CUI [2,3]
- C3469597
Beskrivning
Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
Datatyp
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
Beskrivning
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005794
- UMLS CUI [2]
- C0456388
Beskrivning
Unwillingness or inability to follow the procedures outlined in the protocol.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [2,1]
- C1299582
- UMLS CUI [2,2]
- C0525058
Beskrivning
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.
Datatyp
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
Beskrivning
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.
Datatyp
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])