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A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11
Sponsor: Gates Medical Research Institute
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose trial of TBD11 in healthy adults. It includes a dedicated open-label cohort in which TBD11 will be administered as a single dose with either a strong cytochrome P450 3A (CYP3A) inhibitor (itraconazole) or a strong CYP3A inducer (rifampicin) in 2 trial periods to evaluate DDI. The trial will consist of 3 cohorts; Cohort 1 will occur prior to Cohort 2 and Cohort 3. Cohort 2 and Cohort 3 will start after completion of Cohort 1 and will run in parallel. Cohort 1 will be double-blind and participants will receive 300 mg TBD11 or placebo once daily for 14 days. Cohort 2 will be the open-label DDI cohort. Cohort 3 will be double-blind and participants will receive TBD11 or placebo once daily for 84 days.
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With Up to 84-day Period of Fixed Daily Dosing, With an Evaluation of Drug-Drug Interactions
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-10-21
Completion Date
2027-05-30
Last Updated
2026-10-22
Healthy Volunteers
Yes
Conditions
Interventions
TBD11 (300 mg)
TBD11: TBD11 administered orally at 300 mg
Placebo
Matching placebo administered orally according to the cohort-specific dosing schedule.
Itraconazole (200 mg)
Itraconazole 200 mg orally once daily, with a 400 mg loading dose on the first day of administration.
Rifampicin 600mg
Rifampicin 600 mg orally once daily.
TBD11 (50 mg)
TBD11: TBD11 administered orally at 50 mg
TBD11 (up to 300 mg)
TBD11: TBD11 administered orally at up to 300 mg
Locations (1)
FARMOVS (Pty) Ltd
Bloemfontein, South Africa