A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants

May 11, 2026 updated by: Bristol-Myers Squibb

A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants

The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m^2) and 32.0 kg/m^2, inclusive, at screening.
  • A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

  • Any significant acute or chronic medical illness.
  • Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
  • GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afimetoran, followed by famotidine + afimetoran
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Drug: Famotidine
Specified dose on specified days
Other Names:
  • Pepcid
Experimental: Famotidine + afimetoran, followed by afimetoran
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Drug: Famotidine
Specified dose on specified days
Other Names:
  • Pepcid
Experimental: Afimetoran
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Experimental: Famotidine, followed by afimetoran
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Drug: Famotidine
Specified dose on specified days
Other Names:
  • Pepcid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 20 Days
Up to 20 Days
Time to attain maximum observed plasma concentration (Tmax)
Time Frame: Up to 20 Days
Up to 20 Days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time Frame: Up to 20 Days
Up to 20 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 52 Days
Up to 52 Days
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 52 Days
Up to 52 Days
Number of participants with vital sign abnormalities
Time Frame: Up to 52 Days
Up to 52 Days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 52 Days
Up to 52 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM026-1023
  • 1007296 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Afimetoran

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe