Phenotyping of High Dose Rifampicin
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.
Timeline
- Start
- 2021-01-07
- Primary completion
- 2021-08-12
- Completion
- 2021-08-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Dextromethorphan | Unknown | — | Oral |
| Subject | Digoxin | Other / unclassified | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Omeprazole | Other / unclassified | — | Oral |
| Subject | Rifampin | Small molecule | 10 mg/kg | — |
| Subject | Rifampin | Small molecule | 40 mg/kg | — |
| Subject | Tolbutamide | Small molecule | — | Oral |