Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Atazanavir (current formulation); Drug: Atazanavir, powder for oral use 1 (POU1); Drug: Atazanavir (POU2)

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atazanavir + 10% aspartame	Drug: Atazanavir (current formulation); Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose; Other Names: Reyataz
Active Comparator: Atazanavir + 4.2% aspartame	Drug: Atazanavir, powder for oral use 1 (POU1); Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose; Other Names: Reyataz
Active Comparator: Atazanavir + 4.2% aspartame and sucralose	Drug: Atazanavir (POU2); Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose; Other Names: Reyataz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir	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.	Study Day 1
Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir	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.	Study Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir	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.	Study Day 1
Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir	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.	Study Day 1
Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests		Study Day 1
Number of Participants With Abnormal Findings on Electrocardiograms		Study Day 1
Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Study Day 1
Number of Participants With Clinically Relevant Changes in Vital Signs		Study Day 1

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Atazanavir Sulfate
• Other Study ID Numbers: AI424-466