Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

NCT01404572 | Completed Phase 1 Results

• 1 other identifier: AI424-466
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

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

  Study Day 1

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

  Study Day 1

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

  Study Day 1

• Number of Participants With Abnormal Findings on Electrocardiograms

  Study Day 1

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

  Study Day 1

Study Arms (3)

Atazanavir + 10% aspartame

ACTIVE COMPARATOR

Drug: Atazanavir (current formulation)

Atazanavir + 4.2% aspartame

ACTIVE COMPARATOR

Drug: Atazanavir, powder for oral use 1 (POU1)

Atazanavir + 4.2% aspartame and sucralose

ACTIVE COMPARATOR

Drug: Atazanavir (POU2)

Interventions

Atazanavir (current formulation) DRUG

Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose

Also known as: Reyataz

Atazanavir + 10% aspartame

Atazanavir, powder for oral use 1 (POU1) DRUG

Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose

Also known as: Reyataz

Atazanavir + 4.2% aspartame

Atazanavir (POU2) DRUG

Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose

Also known as: Reyataz

Atazanavir + 4.2% aspartame and sucralose

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Pra International

Lenexa, Kansas, 66219, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

Atazanavir Sulfate; Powders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

This was a taste assessment only; participants did not swallow any treatment blends.

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb (BMS)

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 28, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 10, 2013
• Results First Posted: June 10, 2013

Record last verified: 2013-05

Locations

US (1)