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
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2021
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
June 24, 2021
CompletedStudy Start
First participant enrolled
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2021
CompletedJanuary 21, 2022
January 1, 2022
3 months
June 24, 2021
January 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (20)
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
- +15 more secondary outcomes
Study Arms (2)
Sequence AB
EXPERIMENTALSequence BA
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PPD Development, LP
Austin, Texas, 78744, 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
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2021
First Posted
June 28, 2021
Study Start
June 25, 2021
Primary Completion
September 24, 2021
Study Completion
September 24, 2021
Last Updated
January 21, 2022
Record last verified: 2022-01