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Healthy Adult ParticipantsPhase 1NCT07742384

Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib

A Phase 1 study testing Taletrectinib, Taletrectinib, Famotidine and Taletrectinib,Famotidine in people with Healthy Adult Participants, run by Nuvation Bio Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult Participants
What is being tested?
Taletrectinib, Taletrectinib, Famotidine and Taletrectinib,Famotidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 2 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
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  • 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:
  • Serum total bilirubin: ≤1×ULN.
  • Estimated creatinine clearance (CLcr) ≥90 mL/min as calculated using the methodstandard for the institution (e.g., Cockcroft-Gault Equation).

Who cannot join

  • 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).
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  • 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.
  • Participants who have received any investigational drug, device, biologic, or other agent (within 60 days or 5 half-lives, whichever is longer) prior to study drug administration on Day 1.
  • Participants who are reluctant to stop consuming caffeinated or purine-containing foods (e.g., coffee, tea, cola, chocolate) from 72 hours prior to the first dose of study drug until the EOT/ET visit.
  • History of regular alcohol consumption exceeding 14 drinks/week (1 drink =12 ounces [360 mL] beer, or 5 ounces [150 mL] of wine, or 1.5 ounces [45 mL] of hard liquor), or participants who are unwilling to stop drinking alcohol from 72 hours prior to the first dose of study drug until the EOT/ET visit.
  • Use of tobacco- or nicotine-containing products ≥5 cigarettes per day, or participants who are unwilling/unable to stop tobacco- or nicotine-containing products from 72 hours prior to the first dose of study drug to the EOT/ET visit.
  • A positive urine drug screen.
  • A positive blood or breath test for alcohol.
  • Underwent major surgery within 6 months prior to the first dose of study drug.
  • Blood donation or blood loss within 3 months prior to the first dose of study drug of ≥400 mL.
  • Plasma donation within 30 days prior to the first dose of study drug.
  • Participants with gastrointestinal, liver, kidney disease, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion within 3 months prior to screening and during the Screening Period, or have a medical history of platelet reduction induced by heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the dietary or other guidelines described in this protocol.
  • Participants who are investigational site staff members directly involved in the conduct of the study or are their family members; site staff members otherwise supervised by the Investigator, or participants who are Nuvation Bio employees directly involved in the conduct of the study.
  • Venous access considered inadequate for PK sample collection; history or evidence of adverse symptoms associated with phlebotomy or blood donation.
  • The Investigator judges that the participant is not suitable to participate in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Qian Chen, PhD contact

18621617880

qchen@shxh-centerlab.com

About this study

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

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:

Read more

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.

Read the 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).

Being tested
Taletrectinib, Taletrectinib, Famotidine, Taletrectinib,Famotidine
Keywords
Phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TaletrectinibDrug

    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, FamotidineDrug

    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, FamotidineDrug

    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.

  • TaletrectinibDrug

    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, FamotidineDrug

    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,FamotidineDrug

    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.

Study groups in NCT07742384
Study groupRoleWhat they receive
Taletrectinib 600 mg single dose (Part 1, Treatment A)ExperimentalA 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.
Receives: Drug: Taletrectinib
Famotidine 40mg + taletrectinib 600mg single dose (Part 1,Treatment B).ExperimentalA 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).
Receives: Drug: Taletrectinib, Famotidine
Famotidine 20mg + taletrectinib 600mg + famotidine 20mg single dose (Part 1, Treatment C)ExperimentalA 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.
Receives: Drug: Taletrectinib, Famotidine
Taletrectinib 400mg single dose (Part 2,Treatment A)ExperimentalA 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.
Receives: Drug: Taletrectinib
Famotidine 40mg + taletrectinib 400mg single dose (Or Part 2,Treatment B).ExperimentalA 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.
Receives: Drug: Taletrectinib, Famotidine
Famotidine 20mg + taletrectinib 400mg + famotidine 20mg single dose (Or Part 2, Treatment C)ExperimentalA 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.
Receives: Drug: Taletrectinib,Famotidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of Taletrectinib

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

  2. AUClast of Taletrectinib

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

  3. AUCinf of Taletrectinib

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

Secondary outcomes (22)

  1. Tmax of Taletrectinib

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

  2. λz of Taletrectinib

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

  3. t½ of Taletrectinib

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

  4. CL/F of Taletrectinib

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

  5. Vz/F of Taletrectinib

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

  6. AUCextr% of Taletrectinib

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

  7. Physical Examinations including assessment of general appearance, skin, head and neck, chest, abdomen, spine and limbs, neurologic system

    Measured: About 2 months

  8. Severity of adverse events (AEs) and the number of participants with treatment-emergent adverse event (TEAE)

    Measured: About 2 months

  9. Vital signs: Systolic blood pressure(mmHg)

    Measured: About 2 months

  10. Vital signs: Diastolic blood pressure(mmHg)

    Measured: About 2 months

  11. Vital signs: Heart rate (beats/min)

    Measured: About 2 months

  12. Vital signs: Respiratory rate (breaths/min)

    Measured: About 2 months

  13. Vital signs: Temperature(℃ or C)

    Measured: About 2 months

  14. ECG: Ventricular Rate (bpm or beats/min)

    Measured: About 2 months

  15. ECG: PR interval (msec or ms)

    Measured: About 2 months

  16. ECG: QRS duration (msec or ms)

    Measured: About 2 months

  17. ECG: QT interval (msec or ms)

    Measured: About 2 months

  18. ECG: QTcF (msec or ms)

    Measured: About 2 months

  19. Safety lab abnormality:Hematology

    Measured: About 2 months

  20. Safety lab abnormality:Coagulation

    Measured: About 2 months

  21. Safety lab abnormality:Serum Chemistry

    Measured: About 2 months

  22. Safety lab abnormality:Urinalysis

    Measured: About 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion2 Feb 2027 (estimated)
  4. Study completion2 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07742384
Sponsor's protocol ID
NUV-106-C122
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Taletrectinib, Taletrectinib, Famotidine and Taletrectinib,Famotidine in people with Healthy Adult Participants, run by Nuvation Bio Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qian Chen, PhD (18621617880, qchen@shxh-centerlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Taletrectinib (time frame: Pre-dose to 264 hours post dose on Day 1, Day 15 and Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07742384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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