Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

Bristol-Myers Squibb12 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

HIV

Interventions

Atazanavir (current formulation)DRUG

Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose

Atazanavir, powder for oral use 1 (POU1)DRUG

Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose

Atazanavir (POU2)DRUG

Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pra International

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Study Day 1

Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir

Time frame: Study Day 1

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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