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A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986256 | Drug | specified dose on specified days |
| |
| Mycophenolate Mofetil |
| Measure | Description | Time Frame |
|---|---|---|
| Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax) | days 1-5 and days 26 -30 | |
| mycophenolic acid (MPA) PK parameter: area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC (0-T) | Days 1-5 and Days 26 -30 | |
| Mycophenolic Acid (MPA) PK parameter:area under the concentration-time curve from time zero extrapolated to infinite time AUC (INF) | Days 1-5 and days 26 -30 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | up to 51 days | |
| Incidence of Serious Adverse Events (SAEs) | up to 51 days | |
| Number of Clinically significant changes in lab assessment of blood serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - 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 |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
specified dose on specified days |
|
| up to 51 days |
| Number of Clinically significant changes in assessment of blood | up to 51 days |
| Number of Clinically significant changes in lab assessment of urine | up to 51 days |
| Vital signs of blood pressure | up to 51 days |
| Vital signs of body temperature | up to 51 days |
| Vital signs of respiratory rate | up to 51 days |
| Number of Participants with abnormal physical examination findings | up to 51 days |
| FDA Safety Alerts and Recalls | View source |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |