A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

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

The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986256; Drug: Famotidine

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Development, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence AB	Drug: BMS-986256; Specified dose on specified days; Drug: Famotidine; Specified dose on specified days; Other Names: Pepcid
Experimental: Sequence BA	Drug: BMS-986256; Specified dose on specified days; 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) of BMS-986256	Up to 19 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256	Up to 19 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256	Up to 19 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)		Up to 45 days
Incidence of Serious Adverse Events (SAEs)		Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests		Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 45 days
Incidence of clinically significant changes in vital signs: Body temperature		Up to 45 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 45 days
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 45 days
Incidence of clinically significant changes in vital signs: Heart rate		Up to 45 days
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to 45 days
Incidence of clinically significant changes in ECG parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to 45 days
Incidence of clinically significant changes in ECG parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to 45 days
Incidence of clinically significant changes in ECG parameters: QTcF	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	Up to 45 days
Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)		Up to 45 days
Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)		Up to 45 days
Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)		Up to 45 days
Time of maximum observed plasma concentration (Tmax) of BMS-986256		Up to 45 days
Apparent terminal plasma half-life (T-HALF) of BMS-986256		Up to 45 days
Apparent total body clearance (CLT/F) of BMS-986256		Up to 45 days
Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256		Up to 45 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): September 24, 2021
• Study Completion (Actual): September 24, 2021

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Healthy Participants; Famotidine; BMS-986256; Gastric pH
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine
• Other Study ID Numbers: IM026-029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No