Overview

Phenotyping of High Dose Rifampicin

Status:
Completed
Trial end date:
2021-08-12
Target enrollment:
Participant gender:
Summary
Higher doses of rifampicin as a means of more efficient use of this pivotal TB drug has shown promising results and might become standard in future. This means that higher doses of rifampicin will be co-administered with many other drugs taken by TB patients, including anti-retroviral, anti-diabetic, cardiovascular and other drugs. Therefore, in this study the aim is to quantitatively assess the drug interaction potential of high dose rifampicin (~40 mg/kg daily dose, the currently available maximum tolerated dose) with respect to five major human drug-metabolizing CYP enzymes and P-gp in comparison to the conventional dose of 10 mg/kg daily in pulmonary TB patients. A phenotyping approach with single administration of several selective substrates for multiple enzymes will be used, in order to prevent multiple drug-drug interaction studies.
Phase:
Phase 1
Details
Lead Sponsor:
Radboud University
Treatments:
Caffeine
Dextromethorphan
Digoxin
Midazolam
Omeprazole
Rifampin
Tolbutamide