Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

Study Overview
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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.

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

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

Conditions
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HIV

Intervention / Treatment
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* Drug: Atazanavir (current formulation)
* Drug: Atazanavir, powder for oral use 1 (POU1)
* Drug: Atazanavir (POU2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |