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Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rosuvastatin + BMS-963272 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosuvastatin | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | up to Day 10 | |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T) | up to Day 10 | |
| Area under the plasma concentration-time curve extrapolated to infinity AUC (INF) | up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Approximately 50 days | |
| Number of significant changes in lab assessments of blood serum | Approximately 50 days | |
| Number of significant changes in lab assessments of blood |
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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 could apply
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| 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 |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| BMS-963272 |
| Drug |
Specified dose on specified days |
|
| Approximately 50 days |
| Number of significant changes in lab assessments of urine | Approximately 50 days |
| Blood pressure | Approximately 50 days |
| Body temperature | Approximately 50 days |
| Respiratory rate | Approximately 50 days |
| Number of Participants with abnormal physical examination findings | Approximately 50 days |
| Heart rate | Approximately 50 days |
| Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities | Approximately 50 days |
| FDA Safety Alerts and Recalls | View source |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |