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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
  Purpose

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.


Condition Intervention Phase
HIV
 Drug: Atazanavir
 Phase 4

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:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Scores for overall palatability [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]

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: Arm 1: Atazanavir with 10% Aspartame Drug: Atazanavir
Solution, Oral, Atazanavir 15 mg/5 mL with 10% Aspartame, Single Dose
Other Name: Reyataz
Active Comparator: Arm 2: Atazanavir with 4.2% Aspartame Drug: Atazanavir
Solution, Oral, Atazanavir 15 mg/5 mL with 4.2% Aspartame, Single Dose
Other Name: Reyataz
Active Comparator: Arm 3: Atazanavir with 4.2% Aspartame and Sucralose Drug: Atazanavir
Solution, Oral, Atazanavir 15 mg/5 mL with 4.2% Aspartame and Sucralose, Single Dose
Other Name: Reyataz

Detailed Description:

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

  Eligibility

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

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
  Contacts and Locations
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:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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
Last Updated: September 26, 2011
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 May 16, 2013