Clinical Trial

Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib

Not Yet Recruiting Phase 1
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Summary
This Phase 1 open-label trial aims to evaluate the effect of famotidine on the pharmacokinetics (PK), safety and tolerability of taletrectinib in healthy adult participants. To assess famotidine's impact on key PK parameters of taletrectinib and evaluate other PK parameters as well as safety endpoints. The study design: Part 1: Taletrectinib 600 mg administered under 2-hour fasting condition with three regimens: (Treatment A: Taletrectinib alone, Treatment B: Taletrectinib 2 h after single 40 mg famotidine. Treatment C: Taletrectinib dosed between two 20 mg famotidine doses). Part 2: Taletrectinib 400 mg administered with standard low-fat meal, followed by either Treatment B or C of famotidine co-administration.
Trial Details
NCT Number NCT07742384
Lead Sponsor Nuvation Bio Inc.
Conditions Healthy Adult Participants
Enrollment 56 participants
Start Date 2026-08-01
Primary Completion 2027-02-02 (estimated)
Study Completion 2027-02-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-03