Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404572
• Other study ID #: AI424-466
• Status: Completed
• Phase: Phase 1
• First received: July 27, 2011
• Last updated: May 3, 2013
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Atazanavir (current formulation)
Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose
• Atazanavir, powder for oral use 1 (POU1)
Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose
• Atazanavir (POU2)
Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose

Locations

Country	Name	City	State
United States	Pra International	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir	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.	Study Day 1	No
Primary	Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir	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.	Study Day 1	No
Secondary	Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir	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.	Study Day 1	No
Secondary	Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir	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.	Study Day 1	No
Secondary	Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests		Study Day 1	Yes
Secondary	Number of Participants With Abnormal Findings on Electrocardiograms		Study Day 1	Yes
Secondary	Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Study Day 1	Yes
Secondary	Number of Participants With Clinically Relevant Changes in Vital Signs		Study Day 1	Yes

External Links

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