Clinical trial NCT02307656: Taste Properties of Atazanavir and Cobicistat
Official title: Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV in Adults
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

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
timeFrame: Every 6 weeks from the time of subject enrollment up to 2 years
measure: 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
timeFrame: Every 6 weeks from the time of subject enrollment up to 2 years
measure: 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
timeFrame: Every 6 weeks from the time of subject enrollment up to 2 years
measure: 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
timeFrame: Every 6 weeks from the time of subject enrollment up to 2 years
measure: 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
timeFrame: Every 6 weeks from the time of subject enrollment up to 2 years
Secondary outcomes:
Other outcomes:
measure: Incident of adverse events will be tabulated and reviewed for potential significance and clinical important
timeFrame: Approximately up to 2 years
Locations:
city: Woburn
country: United States
facility: Senopsys Llc
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: