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Completed

NCT Number: NCT04941755

A Study to Determine the Effect of 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 induced by famotidine on the drug levels of BMS-986256.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy participants, defined as having no clinically significant deviations from normal in medical history
  • Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening
  • Normal renal function at screening

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment
  • Any major surgery within 4 weeks of study treatment administration
  • Significant history of GI abnormalities

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

Other names: Pepcid

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986256

    Time frame: Up to 19 days

  2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256

    Time frame: Up to 19 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256

    Time frame: Up to 19 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 45 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 45 days

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

    Time frame: Up to 45 days

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

    Time frame: Up to 45 days

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

    Time frame: Up to 45 days

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

    Time frame: Up to 45 days

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

    Time frame: Up to 45 days

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

    Time frame: Up to 45 days

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

    Time frame: Up to 45 days

  10. Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval

    Time frame: Up to 45 days

    PR interval is the time from the onset of the P wave to the start of the QRS complex

  11. Incidence of clinically significant changes in ECG parameters: QRS

    Time frame: Up to 45 days

    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

  12. Incidence of clinically significant changes in ECG parameters: QT interval

    Time frame: Up to 45 days

    The QT interval is the time from the start of the Q wave to the end of the T wave

  13. Incidence of clinically significant changes in ECG parameters: QTcF

    Time frame: Up to 45 days

    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

  14. Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)

    Time frame: Up to 45 days

  15. Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)

    Time frame: Up to 45 days

  16. Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)

    Time frame: Up to 45 days

  17. Time of maximum observed plasma concentration (Tmax) of BMS-986256

    Time frame: Up to 45 days

  18. Apparent terminal plasma half-life (T-HALF) of BMS-986256

    Time frame: Up to 45 days

  19. Apparent total body clearance (CLT/F) of BMS-986256

    Time frame: Up to 45 days

  20. Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256

    Time frame: Up to 45 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2021
Registry last updated
Jan 21, 2022

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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