Status:
COMPLETED
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
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 th...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01404572
Start Date
August 1 2011
End Date
September 1 2011
Last Update
June 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pra International
Lenexa, Kansas, United States, 66219