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The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental |
| |
| Sequence BA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986256 | Drug | Specified dose on specified days |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Famotidine |
| Drug |
Specified dose on specified days |
|
|
| 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 |
| 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 | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 45 days |
| Incidence of clinically significant changes in ECG parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 45 days |
| Incidence of clinically significant changes in ECG parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave | Up to 45 days |
| Incidence of clinically significant changes in ECG parameters: QTcF | 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 | Up to 45 days |
| 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 |
| FDA Safety Alerts and Recalls | View source |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |