Tuberculosis Clinical Trial
Official title:
Phase I Dose Escalation Study of the Pharmacokinetics, Safety and Tolerability of Rifapentine and the Effects of Increasing Doses of Rifapentine on Induction of Metabolizing Enzymes in Healthy Volunteers
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.
On day 1, volunteers will receive a single dose of MDZ dosed at 15 mg delivered orally, and a
24-hour PK analysis of MDZ and its metabolite, 1-OH-midazolam (1-OH-MDZ) will be performed.
RPT (or RIF) will be given as a single daily dose (5, 10, 15, or 20 mg/kg, depending on the
dose cohort) on days 2-15 (14 doses). A 24-hour PK analysis of RPT (or RIF) and its
25-deacetyl metabolite (25-des-RPT) will be performed after the first dose (day 2). On day
15, volunteers receive a second single dose of MDZ. A 72-hour RPT (or RIF) and 24-hour MDZ
(and 1-OH-MDZ) PK analysis will be performed after the second dose of MDZ beginning on day
15. The PK sampling will occur both on an in-patient basis in the General Clinical Research
Center (GCRC) and on an out-patient basis in the study clinic. Volunteers will undergo
assessments for adverse events (AEs) several times throughout the study.
Each dose cohort will contain 6 subjects. RPT dosing will begin at 5 mg/kg (6 volunteers) and
increase by 5 mg/kg increments (6 volunteers each at 10, 15, and 20 mg/kg) to a maximum dose
of 20 mg/kg unless dose-limiting toxicities (DLT) are seen in two or more patients within a
dose cohort, in which case a dose that is 2.5 mg/kg lower than the previous dose will be
enrolled to determine the maximal tolerated dose (MTD). In addition, one cohort of 6 subjects
will receive RIF at 10 mg/kg daily, rather than RPT, as a comparator arm.
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