NCT04470778CompletedPhase 1
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
Bristol-Myers Squibb1 site in 1 country35 target enrollmentStarted: July 20, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BMS-986256
Experimental
Intervention: BMS-986256 (Drug)
BMS-986256 + Famotidine
Experimental
Intervention: BMS-986256 (Drug)
BMS-986256 + Famotidine
Experimental
Intervention: Famotidine (Drug)
Outcomes
Primary Outcomes
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 39 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T)
Time Frame: Up to 39 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Time Frame: Up to 39 days
Secondary Outcomes
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 67 days)
- 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: 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)
Investigators
Study Sites (1)
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