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The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atazanavir and Cobicistat | Other | Stage 1:Taste evaluation using Active Pharmaceutical Ingredient (API) Stage 2:Taste Optimization using API (flavours and sweeteners) Stage 3:Prototypes of the API - containing clinical trial materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir | Drug |
| ||
| Cobicistat |
| Measure | Description | Time Frame |
|---|---|---|
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years | |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years | |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years | |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years | |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Incident of adverse events will be tabulated and reviewed for potential significance and clinical important | Approximately up to 2 years |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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 |
|---|---|---|---|---|---|---|
| Senopsys Llc | Woburn | Massachusetts | 01801 | 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 |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D000069547 | Cobicistat |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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|
| Active Pharmaceutical Ingredient | Drug |
|
|
| FDA Safety Alerts and Recalls | View source |
| 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 |