A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
- Registration Number
- NCT04941755
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence BA BMS-986256 - Sequence AB Famotidine - Sequence BA Famotidine - Sequence AB BMS-986256 -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) 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 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
- Secondary Outcome Measures
Name Time Method Incidence of clinically significant changes in vital signs: Body temperature Up to 45 days Incidence of clinically significant changes in ECG parameters: QT interval Up to 45 days The QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in ECG parameters: QTcF Up to 45 days QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine) 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: Urinalysis tests Up to 45 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 45 days Incidence of clinically significant changes in ECG parameters: QRS Up to 45 days QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval Up to 45 days PR interval is the time from the onset of the P wave to the start of the QRS complex
Incidence of Adverse Events (AEs) Up to 45 days Incidence of clinically significant changes in vital signs: Blood pressure 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 vital signs: Heart rate Up to 45 days Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine) Up to 45 days Apparent terminal plasma half-life (T-HALF) of BMS-986256 Up to 45 days Apparent total body clearance (CLT/F) of BMS-986256 Up to 45 days Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256 Up to 45 days Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine) Up to 45 days Time of maximum observed plasma concentration (Tmax) of BMS-986256 Up to 45 days
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States