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The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A:Fixed- dose combination mini-tablet | Experimental |
| |
| Treatment B: Separate products taken at the same time | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir/Cobicistat | Drug | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of Atazanavir (ATV) | Up to Day 10 | |
| Cmax of Cobicistat (COBI) | Up to Day 10 | |
| Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV | Up to Day 10 | |
| AUC(INF) of COBI | Up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events (SAEs) | Up to 70 days | |
| Incidence of AEs leading to discontinuation | Up to 40 days | |
| Incidence of deaths |
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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 |
|---|---|---|---|---|---|---|
| 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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| Reyataz Atazanavir | Drug | Specified Dose on Specified Days |
|
|
| Cobicistat | Drug | Specified Dose on Specified Days |
|
|
| Up to 40 days |
| Marked abnormalities in clinical laboratory test results | Up to 40 days |
| Incidence of marked abnormalities in vital sign measurements: Blood Pressure | Up to 40 days |
| Incidence of marked abnormalities in vital sign measurements: Heart Rate | Up to 40 days |
| Incidence of marked abnormalities in Electrocardiogram (ECG) recording | Up to 40 days |
| Incidence of Palatability questionnaire results | Up to 40 days |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D000069547 | Cobicistat |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
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