Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atazanavir + 10% aspartame

Group Type ACTIVE_COMPARATOR

Atazanavir (current formulation)

Intervention Type DRUG

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

Atazanavir + 4.2% aspartame

Group Type ACTIVE_COMPARATOR

Atazanavir, powder for oral use 1 (POU1)

Intervention Type DRUG

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

Atazanavir + 4.2% aspartame and sucralose

Group Type ACTIVE_COMPARATOR

Atazanavir (POU2)

Intervention Type DRUG

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

Interventions

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Atazanavir (current formulation)

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

Intervention Type DRUG

Atazanavir, powder for oral use 1 (POU1)

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

Intervention Type DRUG

Atazanavir (POU2)

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

Intervention Type DRUG

Other Intervention Names

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Reyataz Reyataz Reyataz

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes