Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

February 28, 2011

Study Completion Date

March 31, 2011

Conditions
TuberculosisTuberculosis, Pulmonary
Interventions
DRUG

Rifampin & midazolam

rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15

DRUG

rifapentine & midazolam

rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15

DRUG

rifapentine & midazolam

rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15

DRUG

rifapentine & midazolam

rifapentine - tablet, 15 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15

DRUG

rifapentine and midazolam

rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15

DRUG

rifapentine and midazolam

rifapentine - tablet, 2.5 mg/kg lower than previously tolerated dose cohort, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15

Trial Locations (1)

21287

Johns Hopkins University, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Centers for Disease Control and Prevention

FED

lead

Johns Hopkins University

OTHER