NCT03510468View on ClinicalTrials.gov

Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

June 12, 2018

Primary Completion Date

November 15, 2022

Study Completion Date

December 21, 2022

Conditions
Healthy Volunteers
Interventions
DRUG

Tenofovir alafenamide

Each tablet contains 25 mg of tenofovir alafenamide.

DRUG

Rifapentine

Each tablet contains 150 mg of rifapentine. Participants who weigh 45 to \< 50 kg will take 750 mg (5 tablets), and participants who weigh (Bullet) 50 kg will take 900 mg (6 tablets).

DRUG

Isoniazid (INH)

Each tablet is formulated as 100 or 300 mg of isoniazid.

DIETARY_SUPPLEMENT

Pyridoxine

Each tablet contains 50 mg of pyridoxine

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institutes of Health Clinical Center (CC)

NIH

NCT03510468 - Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA) | Biotech Hunter | Biotech Hunter