Healthy volunteers (Japanese male)
Conditions
Interventions
Drug administration(semi-pharmacological dose of repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam) ->
Drug administration(clinical dose of rifampicin,and semi-pharmacological dose of repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam) ->
Drug administration (clinical dose of itraconazole, and semi-pharmacological dose of repaglinide, clarithromycin, bosentan, simeprevir, darunavir, midazolam)
Sponsors
P-One Clinic,Keikokai Medical Corp.
Sugiyama Laboratory,RIKEN Innovation Center,RIKEN Research Cluster for Innovation. Department of Molecular Pharmacokinetics,Graduate School of Pharmaceutical Sciences,The University of Tokyo.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a) Japanese male subjects at the age of 20-40 at the timing of informed consent b) Person who is judged as an appropriate subject for this clinical study by doctors based on the previous medical history and the results of clinical test at the screening c) BMI of subject should be in the range of 18.5 and 25 at the screening. d) person who can understand and follow the clinical study plan and give us a written informed consent based on the free will
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactDr. Kenichi Furihata
P-One Clinic,Keikokai Medical Corp. Chairman
Outcome results
None listed