Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib
brief 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.
detailed description
Part 1 (taletrectinib 600 mg, 2-hour fast):
Treatment A: taletrectinib 600 mg administered 2 hours after a standard low-fat meal(Period 1).
Treatment B: taletrectinib 600 mg administered 2 hours after famotidine 40 mg given with a standard low-fat meal (Period 2).
Treatment C: taletrectinib 600 mg administered 10 hours after the first 20-mg famotidine dose, 2 hours after a standard low-fat meal, and 2 hours before the second 20-mg famotidine dose (Period 3).
Part 2 (taletrectinib 400 mg with a standard low-fat meal):
Treatment A: taletrectinib 400 mg within 30 min and no longer than 1 hour after a standard low-fat meal (Period 1).
Followed by either Treatment B or Treatment C Treatment B: taletrectinib 400 mg administered within 30 min and no longer than 1 hour after a standard low-fat meal and 2 hours after famotidine 40 mg (Period 2/Treatment B). Treatment C: taletrectinib 400 mg administered within 30 min and no longer than 1 hour after a standard low-fat meal, 10 hours after the first 20-mg famotidine dose, and 2 hours before the second 20-mg famotidine dose (Period 2/Treatment C).
official title
An Open-label, Fixed Sequence Study to Evaluate the Effect of Famotidine on the Pharmacokinetics and Safety of Taletrectinib in Healthy Adult Participant