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Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

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

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome:

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

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

Secondary outcome:

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

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

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

Number of Participants With Abnormal Findings on Electrocardiograms

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

Number of Participants With Clinically Relevant Changes in Vital Signs

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

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Both.

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

Locations and Contacts

Pra International, Lenexa, Kansas 66219, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: August 2011
Last updated: May 3, 2013

Page last updated: August 23, 2015

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