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

NCT ID: NCT05866627

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-04

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Afimetoran, followed by famotidine + afimetoran

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Specified dose on specified days

Afimetoran

Intervention Type DRUG

Specified dose on specified days

Famotidine + afimetoran, followed by afimetoran

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Specified dose on specified days

Afimetoran

Intervention Type DRUG

Specified dose on specified days

Afimetoran

Group Type EXPERIMENTAL

Afimetoran

Intervention Type DRUG

Specified dose on specified days

Famotidine, followed by afimetoran

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Specified dose on specified days

Afimetoran

Intervention Type DRUG

Specified dose on specified days

Interventions

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Famotidine

Specified dose on specified days

Intervention Type DRUG

Afimetoran

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Pepcid BMS-986256

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Quotient Sciences

Nottingham, Nottinghamshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

First line of the email MUST contain the NCT# and Site #.

Role: CONTACT

Facility Contacts

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Philip Evans, Site 0001

Role: primary

4401159749000

Related Links

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Other Identifiers

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1007296

Identifier Type: OTHER

Identifier Source: secondary_id

IM026-1023

Identifier Type: -

Identifier Source: org_study_id

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