Drug-drug interaction study with the cocktail administration of semi-pharmacological dose of multiple drugs to determine the quantitative contribution of OATPs and CYP3A4 to the clearance of the substrate drugs of both OATPs and CYP3A4.
- Conditions
- Healthy volunteers (Japanese male)
- Registration Number
- JPRN-UMIN000024790
- Lead Sponsor
- P-One Clinic,Keikokai Medical Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 8
Not provided
a) Subjects who have any hypersensitivity to repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam, rifampicin, itraconazole. b) Subjects who is suffering from acute narrow-angle glaucoma. c) Subjects who is suffering from hypotension( systolic blood pressure < 100mmHg ), hypertension (systolic blood pressure > 140mmHg), diabetes and anemia ( Hb < 12.0g/dL ) at the timing of the screening. d) Subjects who donated or lost over 200 mL (1 unit ) of blood in the past 4weeks or over 400mL (2 units) of blood in the past 3months. e) Subjects who suffer/suffered from severe nervous disease, celebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including disease which is expected to affect the absorption of test drugs), respiratory disease and metabolic disease. f) Subjects who is confirmed to have severe clinical abnormalities judged by the diagnostics or physical examination by chief doctor or associate doctors. g) Subjects who is suffering from clinically severe diseases within 30 days before the administration of test drugs. h) Subjects who take medicine, health foods including St. John's wort, foods or drinks containing greapefruit, orange, and apple, and supplements, and cannot stop taking these during this clinical study. i) Subjects who smoke or take nicotine within 30 days before the administration of test drugs, and cannot stop smoking during this clinical study j) Subjects who take foods/drinks containing alcohol or caffeine one day before the date of hospital admission, and cannot stop taking these until the final day of this study. k) Subjects whose results of alcohol breath test or uninary drug screening are positive at the timing of screening. l) Subjects whose results of any tests of serological reaction for HBs antigen, HCV antibody or HIV antigen and antibody are positive m) Subjects who is not suitable for this study judged by chief doctor or associte doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the quantitative contributions of OATPs and CYP3A4 as determinants of the pharmacokinetics of repaglinide, clarithromycin, bosentan, simeprevir and darunavir in Japanese healthy male adults
- Secondary Outcome Measures
Name Time Method Genetic polymorphisms of pharmacokinetics-related genes to modify the pharmacokinetics of repaglinide, clarithromycin, bosentan, simeprevir and darunavir Search for the endogenous biomarkers of metabolic enzymes and transporters by metabolomic analysis of endogenous compounds in the absence and presence of rifampicin or itraconazole