drugset / Trial / NCT01162486
Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers
Phase 1
Completed
37 enrolled
Johns Hopkins University
Centers for Disease Control and Prevention · collabSanofi · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam (MDZ); and (3) the effect of increasing doses of RPT on autoinduction of RPT metabolism.
Timeline
- Start
- 2010-04
- Primary completion
- 2011-02
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Midazolam | Small molecule | 15 mg | Oral |
| Comparator | Rifampin | Small molecule | 10 mg/kg | — |
| Subject | Rifapentine | Small molecule | 5 mg/kg | Oral |
| Subject | Rifapentine | Small molecule | 10 mg/kg | Oral |
| Subject | Rifapentine | Small molecule | 15 mg/kg | Oral |
| Subject | Rifapentine | Small molecule | 20 mg/kg | Oral |