Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib

NCT07742384 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: NUV-106-C122
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Adult Participants

Keywords

Phase I

Outcome Measures

Primary Outcomes (3)

• Cmax of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

• AUClast of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

• AUCinf of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

Secondary Outcomes (22)

• Tmax of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

• λz of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

• t½ of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

• CL/F of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

• Vz/F of Taletrectinib

  Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30

Study Arms (6)

Taletrectinib 600 mg single dose (Part 1, Treatment A)

EXPERIMENTAL

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 40mg + taletrectinib 600mg single dose (Part 1,Treatment B).

EXPERIMENTAL

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

Famotidine 20mg + taletrectinib 600mg + famotidine 20mg single dose (Part 1, Treatment C)

EXPERIMENTAL

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.

Drug: Taletrectinib, Famotidine

Taletrectinib 400mg single dose (Part 2,Treatment A)

EXPERIMENTAL

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 40mg + taletrectinib 400mg single dose (Or Part 2,Treatment B).

EXPERIMENTAL

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

Famotidine 20mg + taletrectinib 400mg + famotidine 20mg single dose (Or Part 2, Treatment C)

EXPERIMENTAL

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,Famotidine

Interventions

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 600 mg single dose (Part 1, Treatment A)

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).

Famotidine 40mg + taletrectinib 600mg single dose (Part 1,Treatment B).

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.

Famotidine 20mg + taletrectinib 400mg + famotidine 20mg single dose (Or Part 2, Treatment C)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Body weight is greater than 50.0 kg at Screening and the body mass index (BMI) is between 19 and 26 kg/m2.
• Males and/or females who meet any of the following criteria:
• For males (irrespective of surgical sterilization \[vasectomy\]): agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of study drug or agree with complete abstinence; and agree not to donate sperm during this same time period.
• Females without menses for at least 1 year prior to Screening or documented to be surgically sterilized. Females of childbearing potential (FOCBP) must agree to use 2 concurrent highly effective methods of contraception or agree with complete abstinence from sexual intercourse from signing of the ICF until 45 days after the last dose of study drug. Usage of hormonotherapy for contraception should be recorded as well.
• For all females of childbearing potential, a negative pregnancy test must be obtained within 1 day before the first dose of study drug. Female participants of non-childbearing potential must meet at least 1 of the following criteria:
• Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
• Have undergone a documented hysterectomy and/or bilateral oophorectomy.
• Have medically confirmed ovarian failure. All other female participants (including female participants with tubal ligations) are considered to be of childbearing potential.
• Must agree to avoid strenuous exercise from 72 hours prior to dosing on Day 1 of Period 1 until the EOT/ET visit.
• Able to sign the informed consent and to comply with the protocol.
• Patients with adequate organ function meeting the following criteria:

You may not qualify if:

• 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.
• Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality including but not limited to any of the following at Screening and Admission,repeat testing is allowed for verification, at the discretion of the Investigator:
• Heart rate \<50 beats per minute (bpm) or \>100 bpm (taken during supine blood pressure measurement).
• Systolic blood pressure \<90 mmHg or ≥140 mmHg; diastolic blood pressure \<50 mmHg or ≥90 mmHg (supine blood pressure measurement).
• The 12-lead ECG shows that the QTc is \>450 milliseconds (msec) or the QRS duration exceeds \>120 msec. If the QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc and QRS values should be used to determine the participant's eligibility.
• History of febrile illness within 5 days prior to the first dose of study drug.
• Positive blood screen for human Hepatitis B virus surface antigen, hepati is C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody.
• Pregnancy or lactation/breastfeeding.
• Use of food or drugs that are known to be strong or moderate cytochrome P450 (CYP)3A4/5 inhibitors or inducers or to be P-glycoprotein inhibitors within 14 days prior to the first dose of study drug until the EOT/ET visit.
• Consumption of Seville oranges or grapefruit-containing foods or beverages within 14 days prior to the first dose of study until the EOT/ET visit.
• Participants who have used prescription or over-the-counter (OTC) medication (other than ≤2 g/day acetaminophen or ≤800 mg/day ibuprofen or allowed contraception methods), vitamins, or herbal remedies, within 2 weeks or 5 half-lives before study drug administration, whichever is longer.
• Participants who have received live vaccines or attenuated vaccines within 28 days prior to the first dose of study drug until the EOT/ET visit.

Sponsors & Collaborators

• Nuvation Bio Inc.: lead

MeSH Terms

Interventions

taletrectinib; Famotidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Qian Chen, PhD

CONTACT

18621617880; qchen@shxh-centerlab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share