Taste Properties of Atazanavir and Cobicistat

Phase 1

Completed

• Conditions: HIV in Adults
• Interventions: Drug: Atazanavir; Drug: Cobicistat; Drug: Active Pharmaceutical Ingredient

• Registration Number: NCT02307656
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Study Start: 2014-12-12
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atazanavir and Cobicistat	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 and Cobicistat	Cobicistat	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 and Cobicistat	Atazanavir	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Senopsys Llc; 🇺🇸 Woburn, Massachusetts, United States