Healthy Participants
Conditions
Keywords
Healthy Participants, BMS-986256, Famotidine, Gastric pH
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.
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
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 45 days | — |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 45 days | — |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 45 days | — |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 45 days | — |
| 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 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 Adverse Events (AEs) | Up to 45 days | — |
| 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 | — |
| Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine) | 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 | — |
| 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 | — |
| 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 Serious Adverse Events (SAEs) | Up to 45 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 45 days | — |
Countries
United States
Outcome results
None listed