Taste Properties of Atazanavir and Cobicistat

NCT02307656 — Phase 1, Completed, 6 participants, Bristol-Myers Squibb

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Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults

Registry	NCT02307656
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, other
Enrollment	6 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	HIV in Adults
Interventions	Atazanavir, Cobicistat, Active Pharmaceutical Ingredient (Drug)
Dates	start 2014-12-12, primary completion 2021-09-09, completion 2021-09-09, first posted 2014-12-04, last updated 2022-01-05
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Atazanavir and Cobicistat	Other	Drug: Atazanavir; Drug: Cobicistat; Drug: Active Pharmaceutical Ingredient	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

Atazanavir (Drug)
Cobicistat (Drug)
Active Pharmaceutical Ingredient (Drug), also known as (API)

+Outcome measures

Primary outcomes

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]

Other outcomes

Incident of adverse events will be tabulated and reviewed for potential significance and clinical important [Approximately up to 2 years]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women, ages ≥18 years
* Subjects who are qualified professional sensory panelists
* Healthy subjects as determined by no clinically significant deviation from normal in medical history and physical assessment

Exclusion Criteria:

* Any acute or chronic condition that may alter taste or smell sensory perception
* Any significant acute or chronic medical illness or any surgery within 4 weeks of the study drug administration
* Positive HIV test using an oral swab kit (such as OraQuick®) to detect HIV-1 or -2 antibody

+Locations (1)

Facility	City	Country	Status
Senopsys Llc	Woburn, Massachusetts	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb