Healthy Participants
Conditions
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.
Interventions
DRUGBMS-986256
Specified dose on specified days
DRUGFamotidine
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 12-Lead electrocardiogram (ECG) parameters | 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 vital signs: Body temperature | Up to 74 days |
| Incidence of Adverse Events (AEs) | Up to 47 days |
| Incidence of Serious Adverse Events (SAEs) | Up to 74 days |
Countries
United States
Outcome results
None listed