Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01404572
First received: July 27, 2011
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
HIV
Drug: Atazanavir (current formulation)
Drug: Atazanavir, powder for oral use 1 (POU1)
Drug: Atazanavir (POU2)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]
    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.

  • Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests [ Time Frame: Study Day 1 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Findings on Electrocardiograms [ Time Frame: Study Day 1 ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Study Day 1 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Clinically Relevant Changes in Vital Signs [ Time Frame: Study Day 1 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atazanavir + 10% aspartame Drug: Atazanavir (current formulation)
Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose
Other Name: 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 Name: 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 Name: Reyataz

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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404572

Locations
United States, Kansas
Pra International
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01404572     History of Changes
Other Study ID Numbers: AI424-466
Study First Received: July 27, 2011
Results First Received: March 13, 2013
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014