Taste Properties of Atazanavir and Cobicistat

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: HIV in Adults

Treatments: Drug: Active Pharmaceutical Ingredient; Drug: Atazanavir; Drug: Cobicistat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02307656

AI424-517

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Atazanavir and Cobicistat

Other group

Description:

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

Treatment:

Drug: Cobicistat

Drug: Atazanavir

Drug: Active Pharmaceutical Ingredient