Skip to main content
OpenTrials
Completed

NCT Number: NCT04470778

Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

The purpose of this study is to investigate the effect of gastric pH changes due to famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in healthy participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON (LPRA) - Salt Lake

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Healthy participants having no clinically significant deviations from normal in medical history, physical examination (PE) findings, electrocardiograms (ECGs), vital signs, and clinical laboratory results that would compromise the ability to participate, complete, and/or interpret the results of the study
  • Weight ≥ 50 kg and body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 inclusive at screening
  • Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • Any significant acute or chronic medical illness
  • Any major surgery within 4 weeks of study treatment administration
  • Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986256

Drug

Specified dose on specified days

Famotidine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 39 days

  2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T)

    Time frame: Up to 39 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)

    Time frame: Up to 39 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 47 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 74 days

  3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: Up to 67 days

  4. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: Up to 67 days

  5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: Up to 67 days

  6. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 74 days

  7. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 74 days

  8. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 74 days

  9. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 74 days

  10. Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters

    Time frame: Up to 74 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2020
Registry last updated
Feb 6, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.