Drug-Drug Interaction Between Rifampin and Fluvastatin
Status:
Completed
Trial end date:
2020-04-25
Target enrollment:
Participant gender:
Summary
The effect of organic anion transporting polypeptide 1B1 (OATP1B1) transporter inhibition at
clinical doses of fluvastatin, a biopharmaceutics drug disposition classification system
(BDDCS) class 1 drug, has not been studied to date. A single dose of IV rifampin can be used
as model OATP1B1 inhibitor to evaluate the significance of OATP1B1 transporter effects on
fluvastatin disposition. A preinduction regimen of oral rifampin followed by a single IV
infusion of rifampin can be used to evaluate the combined effects of enzyme induction and
OATP1B1 transporter inhibition on fluvastatin disposition. A two arm, randomized, open label,
crossover clinical study in healthy, volunteers will be conducted to evaluate the effects of
IV rifampin on fluvastatin disposition in both hepatically induced and uninduced subjects.