Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

February 28, 2020

Study Completion Date

February 28, 2020

Conditions
Multi-drug Resistant Tuberculosis
Interventions
DRUG

Pretomanid

"1. Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.~2. Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.~3. Treatment C (test) = single 50-mg dispersible tablet, orally administered.~4. Treatment D (test) = single 10-mg dispersible tablet, orally administered."

Trial Locations (1)

78217

Worldwide Clinical Trials Early Phase Services, LLC, San Antonio

All Listed Sponsors
lead

Global Alliance for TB Drug Development

OTHER

NCT04309656 - Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid | Biotech Hunter | Biotech Hunter