Clinical trial NCT01404572: Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Official title: Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU.

Detailed description: This study is a taste assessment study designed to select a new atazanavir powder for oral use (POU) formulation that is similar in sweetness to the current POU formulation. Participants were to taste and then spit out the POU formulations, without swallowing them. Study Classification: Other. This is a taste study

Eligibility criteria: Key inclusion criteria:

* Healthy men and women, ages 18 to 49, inclusive
* Nonsmokers
* Women not pregnant or breastfeeding
* Participants who could match solutions of the same sweetness and provide consistent sweetness scores during the taste screening

Key exclusion criteria:

* Any significant acute or chronic medical illness
* Any acute or chronic condition that may have altered taste sensory perception
* Any major surgery or trauma within 4 weeks of Day 1
* Blood transfusion within 4 weeks of study participation
* Recent (within 6 months of Day 1) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse
* Positive urine drug screen
* Positive urine screen for cotinine
* Positive hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibodies
* Clinically significant elevations in results of liver function tests above normal range

Primary outcomes:
measure: Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
timeFrame: Study Day 1
measure: Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
timeFrame: Study Day 1
Secondary outcomes:
measure: Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir
timeFrame: Study Day 1
measure: Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
timeFrame: Study Day 1
measure: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
timeFrame: Study Day 1
measure: Number of Participants With Abnormal Findings on Electrocardiograms
timeFrame: Study Day 1
measure: Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Study Day 1
measure: Number of Participants With Clinically Relevant Changes in Vital Signs
timeFrame: Study Day 1
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pra International
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: