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

July 27, 2011
May 3, 2013
August 2011
September 2011   (final data collection date for primary outcome measure)
  • 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.
To compare scores for sweetness of 2 new powder for oral use to the current Atazanavir [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01404572 on ClinicalTrials.gov Archive Site
  • 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 ]
Scores for overall palatability [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation 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.

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

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
HIV
  • Drug: Atazanavir (current formulation)
    Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose
    Other Name: Reyataz
  • Drug: Atazanavir, powder for oral use 1 (POU1)
    Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose
    Other Name: Reyataz
  • Drug: Atazanavir (POU2)
    Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose
    Other Name: Reyataz
  • Active Comparator: Atazanavir + 10% aspartame
    Intervention: Drug: Atazanavir (current formulation)
  • Active Comparator: Atazanavir + 4.2% aspartame
    Intervention: Drug: Atazanavir, powder for oral use 1 (POU1)
  • Active Comparator: Atazanavir + 4.2% aspartame and sucralose
    Intervention: Drug: Atazanavir (POU2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01404572
AI424-466
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP