Overview

This trial is active, not recruiting.

Condition hiv (adult)
Treatments atazanavir, cobicistat, active pharmaceutical ingredient
Phase phase 1
Sponsor Bristol-Myers Squibb
Start date November 2014
End date July 2017
Trial size 6 participants
Trial identifier NCT02307656, AI424-517

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(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
atazanavir
cobicistat
active pharmaceutical ingredient (API)

Primary Outcomes

Measure
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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: Every 6 weeks from the time of subject enrollment up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.