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Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib

NCT07742384 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

Taletrectinib

A single oral dose of taletrectinib 400 mg dosed within 30 min (no longer than 1 hour) after a meal, on the morning of Part 2 Treatment A Day 1.

DRUG

Taletrectinib, Famotidine

A single oral dose of 40 mg famotidine and 2 hours later, taletrectinib 400 mg will be dosed within 30 min (no longer than 1 hour) after a meal.

DRUG

Taletrectinib,Famotidine

A single oral dose of 20 mg famotidine. On the morning of Day 2 of Part 2 Treatment C, taletrectinib 400 mg should be administered within 30 min and no longer than 1 hour after a meal, 10 hours after the famotidine dose from the prior evening; a final oral dose of 20 mg famotidine will be administrated 2 hours later.

DRUG

Taletrectinib

A single oral dose of taletrectinib 600 mg 2 hours after a meal (2-hour fast),on the morning of Part 1, Treatment A Day 1.

DRUG

Taletrectinib, Famotidine

A single oral dose of famotidine 40mg administered with a meal on the morning of Part 1, Treatment B Day 1, and taletrectinib 600mg administered orally 2 hours later (2-hour fast).

DRUG

Taletrectinib, Famotidine

A single oral dose of famotidine 20mg administered to each participant on the night of Day 1. On the morning of Day 2, 8 hours after the prior dose of famotidine, participants will eat a meal and then be administered taletrectinib 600mg after a 2-hour fast; a final single oral dose of famotidine 20mg will be administered 2 hours after the dose of taletrectinib.

Sponsors & Collaborators

  • Nuvation Bio Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-02-02
Completion
2027-02-02
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742384 on ClinicalTrials.gov