Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
- Conditions
- HIV
- Interventions
- Drug: Atazanavir (POU2)Drug: Atazanavir (current formulation)Drug: Atazanavir, powder for oral use 1 (POU1)
- Registration Number
- NCT01404572
- Lead Sponsor
- Bristol-Myers Squibb
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Atazanavir + 4.2% aspartame and sucralose Atazanavir (POU2) - Atazanavir + 10% aspartame Atazanavir (current formulation) - Atazanavir + 4.2% aspartame Atazanavir, powder for oral use 1 (POU1) -
- Primary Outcome Measures
Name Time Method Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir Study Day 1 Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.
Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir Study Day 1 Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) Study Day 1 Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir Study Day 1 Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.
Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir Study Day 1 Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.
Number of Participants With Abnormal Findings on Electrocardiograms Study Day 1 Number of Participants With Clinically Relevant Changes in Vital Signs Study Day 1 Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests Study Day 1
Trial Locations
- Locations (1)
Pra International
🇺🇸Lenexa, Kansas, United States