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
1 other identifier
interventional
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedStudy Start
First participant enrolled
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2021
CompletedFebruary 6, 2025
November 1, 2022
8 months
July 13, 2020
February 4, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
BMS-986256
EXPERIMENTALBMS-986256 + Famotidine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON (LPRA) - Salt Lake
Salt Lake City, Utah, 84124, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 14, 2020
Study Start
July 20, 2020
Primary Completion
March 21, 2021
Study Completion
March 28, 2021
Last Updated
February 6, 2025
Record last verified: 2022-11