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The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence Group 1 | Experimental |
| |
| Treatment Sequence Group 2 | Experimental |
| |
| Treatment Sequence Group 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 17 days | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to 17 days | |
| Apparent terminal plasma half-life (T-HALF) | Up to 17 days | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) |
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Inclusion Criteria:
• Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/[height(m)]^2
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 |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Miami | Florida | 33136 | 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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| Cobicistat | Drug | Specified dose on specified days |
|
|
| Atazanavir/Cobicistat Mini-tablet | Drug | Specified dose on specified days |
|
|
| Up to 17 days |
| Observed plasma concentration at 24 hours (C24) | Up to 17 days |
| Number of participants with Adverse Events (AEs) | Up to 75 days |
| Number of participants with Serious Adverse Events (SAEs) | Up to 75 days |
| Number of participants with AEs leading to discontinuation | Up to 75 days |
| Number of participants with AEs leading to death | Up to 75 days |
| Number of participants with clinical laboratory abnormalities | Up to 17 days |
| Number of participants with vital sign abnormalities | Up to 17 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 17 days |
| Changes in Taste Evaluation Questionnaire | Palatability evaluated on a scale from 1 (weak) to 9 (strong) | Up to 17 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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