OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO ASSESS THE DOSE-DEPENDENT EFFECT OF RIFAMPICIN ON THE PHARMACOKINETICS OF ENDOGENOUS BIOMARKERS AND PROBE DRUGS FOR ASSESSMENT OF DRUG-DRUG INTERACTIONS MEDIATED BY OATP1B
- Conditions
- Healthy volunteers (Japanese male)
- Registration Number
- JPRN-UMIN000033695
- 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
1.a history of hypersensitivity to atorvastatin, pitavastatin, rosuvastatin, valsartan and rifampicin 2.lactose intolerance 3.hypotension (systolic blood pressure <90 mmHg) or hypertension (systolic blood pressure >160 mmHg) 4.donated or lost 200 mL (1 unit) of blood within 4 weeks before administration of study drugs or 400 mL (2 units) of blood within 3 months before administration of study drugs 5.a medical history/complication of severe nerve disease, cerebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including digestive system disease which is considered to affect the absorption of study drugs), respiratory disease, metabolic disease, and anemia 6.known to have Gilberts Disease, and/or Rotor syndrome 7.confirmed of a clinically severe abnormality based on medical examination or physical examination by the investigator or subinvestigator 8.a clinically severe disease within 30 days before administration of study drugs 9.took drugs, health food including St. Johns wort, food 14 days prior to dosing and beverages including grapefruit, orange and apple (including food containing them), and nutritional supplements 7 days prior to dosing and cannot comply with prohibition of taking them during the study 10.smoking or taking nicotine within 30 days before administration of study drugs and who cannot comply with smoking cessation during the study period 11.took alcohol/caffeine-containing food on the day before hospitalization in each study period and cannot comply with prohibition of taking them until the day of discharge in each study period 12.tested positive in an alcohol breath test/urine drug test at screening 13.cannot discontinue the use of drugs other than study drugs from 2 weeks before administration of study drugs until the study completion 14.positive to HBs antigens, HCV antibodies, or HIV antigens/antibodies 15.judged inappropriate by the investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentrations of coproporphyrins, total and direct bilirubin, bile acids (including glucuronide and sulfate conjugates), and 7a-hydroxy-4-cholesten-3-one, effect of the administration of rifampicin Plasma concentrations of atorvastatin, pitavastatin, rosuvastatin, valsartan and rifampicin, and their metabolites, effect of the coadministration of rifampicin, pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Effect of genetic polymorphisms of OATP1B1 and other transporters and metabolizing enzymes related to the disposition of the probe drugs and endogenous substrates