Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

August 10, 2024

Study Completion Date

October 28, 2024

Conditions
Renal ImpairmentTuberculosis
Interventions
DRUG

PA-824

PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment that is being investigated for use with other TB drugs to shorten and/or simplify regimens to treat either drug susceptible or resistant disease. After fasting for a minimum of 8 hours, subjects will receive one dose of 200 mg of pretomanid orally under direct supervision with 240 mL of water and a mouth check will be done.

Trial Locations (3)

33147

Advanced Pharma - Miami, Miami

37920

Alliance for Multispecialty Research, LLC - Knoxville, Knoxville

63104-1015

Saint Louis University Center for Vaccine Development, St Louis

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03896750 - Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function | Biotech Hunter | Biotech Hunter