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NCT Number: NCT01404572

Taste Assessment Study of 2 Atazanavir Powder Formulations 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.

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Key information

Conditions

HIV

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pra International

Lenexa, Kansas, 66219, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atazanavir (current formulation)

Drug

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

Other names: Reyataz

Atazanavir, powder for oral use 1 (POU1)

Drug

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

Other names: Reyataz

Atazanavir (POU2)

Drug

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

Other names: Reyataz

Primary outcomes

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

    Time frame: 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.

  2. 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

    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 outcomes

  1. Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir

    Time frame: 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.

  2. Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir

    Time frame: 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.

  3. Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests

    Time frame: Study Day 1

  4. Number of Participants With Abnormal Findings on Electrocardiograms

    Time frame: Study Day 1

  5. Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Study Day 1

  6. Number of Participants With Clinically Relevant Changes in Vital Signs

    Time frame: Study Day 1

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2011
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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