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Taste Assessment Study of Two 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: September 26, 2011
Last verified: September 2011
History of Changes

July 27, 2011
September 26, 2011
August 2011
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01404572 on ClinicalTrials.gov Archive Site
Scores for overall palatability [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Taste Assessment Study of Two 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 (ATV) powder for oral use (POU) formulations to the current ATV POU in healthy subjects and to select one ATV POU that has the sweetness most similar to the current ATV POU.

Primary Purpose: This study is a taste assessment study to select a new Atazanavir powder for oral use (POU) formulation that is similar sweetness to the current POU formulation. Subjects will be tasting and then spitting the POU formulations and will not be swallowing the POU formulations that will be tested.

Study Classification: Other. This is a taste study
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
HIV
  • Drug: Atazanavir
    Solution, Oral, Atazanavir 15 mg/5 mL with 10% Aspartame, Single Dose
    Other Name: Reyataz
  • Drug: Atazanavir
    Solution, Oral, Atazanavir 15 mg/5 mL with 4.2% Aspartame, Single Dose
    Other Name: Reyataz
  • Drug: Atazanavir
    Solution, Oral, Atazanavir 15 mg/5 mL with 4.2% Aspartame and Sucralose, Single Dose
    Other Name: Reyataz
  • Active Comparator: Arm 1: Atazanavir with 10% Aspartame
    Intervention: Drug: Atazanavir
  • Active Comparator: Arm 2: Atazanavir with 4.2% Aspartame
    Intervention: Drug: Atazanavir
  • Active Comparator: Arm 3: Atazanavir with 4.2% Aspartame and Sucralose
    Intervention: Drug: Atazanavir
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)

Inclusion Criteria:

  • Healthy men and women, ages 18 to 49, inclusive
  • Nonsmokers
  • Women not pregnant or breastfeeding
  • Subjects who can match solutions that are the same in sweetness and provide consistent sweetness scores during the taste screening

Exclusion Criteria:

  • Positive urine drug screen (UDS)
  • Positive urine screen for cotinine
  • Positive Hepatitis C antibody, Hepatitis B surface antigen, or Human Immunodeficiency Virus antibodies
  • Clinically significant elevations 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
September 2011

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