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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986256 | Experimental |
| |
| BMS-986256 + Famotidine | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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: Hematology tests |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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 |
|---|---|---|---|---|---|---|
| ICON (LPRA) - Salt Lake | Salt Lake City | Utah | 84124 | 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 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 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 |
| FDA Safety Alerts and Recalls | View source |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |