Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate

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