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OpenTrials
Completed

NCT Number: NCT05866627

A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Famotidine

Drug

Specified dose on specified days

Other names: Pepcid

Afimetoran

Drug

Specified dose on specified days

Other names: BMS-986256

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 20 Days

  2. Time to attain maximum observed plasma concentration (Tmax)

    Time frame: Up to 20 Days

  3. 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

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 52 Days

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 52 Days

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 52 Days

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 52 Days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 19, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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