Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib

ConditionHealthy Adult Participants

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorNuvation Bio Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The participant must voluntarily sign an Informed Consent Form (ICF) prior to any study-related procedures.

Participants are able to communicate well with Investigators and complete the study in accordance with the protocol.

Between the ages of 18 and 55 years (inclusive) at the time of signing the ICF.

Healthy adult participants (healthy refers to the status of no clinically relevant abnormalities identified through medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory examinations).

Disqualifiers

Evidence or history of clinically significant hematology, kidney, endocrine, lung, gastrointestinal, cardiovascular, liver, mental, neurological, or allergic diseases (including drug allergies, but not including untreated, asymptomatic seasonal allergies at the time of dosing).

According to the Investigator's judgment, there are clinically significant abnormal laboratory results (hematology, serum chemistry, coagulation, and urinalysis).

Any active or unstable medical condition as judged by the Investigator.

The Investigator believes that the participant may be at increased risk of eye disease or have a history of eye disease, such as glaucoma, retinal shedding, glass turbidity, moth disease,etc.

Trial design

Design model

Crossover

Treatments tested in this trial

Taletrectinib
Drug
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.
Taletrectinib, Famotidine
Drug
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).
Taletrectinib, Famotidine
Drug
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.
Taletrectinib
Drug
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.
Taletrectinib, Famotidine
Drug
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.
Taletrectinib,Famotidine
Drug
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.

Treatment groups

56 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Group A: Taletrectinib 600 mg single dose (Part 1, Treatment A)Experimental treatment 1 intervention

Group B: Famotidine 40mg + taletrectinib 600mg single dose (Part 1,Treatment B).Experimental treatment 1 intervention

Group C: Famotidine 20mg + taletrectinib 600mg + famotidine 20mg single dose (Part 1, Treatment C)Experimental treatment 1 intervention

Group D: Taletrectinib 400mg single dose (Part 2,Treatment A)Experimental treatment 1 intervention

Group E: Famotidine 40mg + taletrectinib 400mg single dose (Or Part 2,Treatment B).Experimental treatment 1 intervention

Group F: Famotidine 20mg + taletrectinib 400mg + famotidine 20mg single dose (Or Part 2, Treatment C)Experimental treatment 1 intervention