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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON (PRA Health Sciences) - Salt Lake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986256	Drug: BMS-986256; Specified dose on specified days
Experimental: BMS-986256 + Famotidine	Drug: BMS-986256; Specified dose on specified days; Drug: Famotidine; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to 39 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T)	Up to 39 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)	Up to 39 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Up to 47 days
Incidence of Serious Adverse Events (SAEs)	Up to 74 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 67 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests	Up to 67 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Up to 67 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 74 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 74 days
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 74 days
Incidence of clinically significant changes in vital signs: Heart rate	Up to 74 days
Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters	Up to 74 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): July 20, 2020
• Primary Completion (Actual): March 21, 2021
• Study Completion (Actual): March 28, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• 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: IM026-028

Drug and device information, study documents

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