Taste Properties of Atazanavir and Cobicistat

Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults

The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.

Study Overview

• Status: Completed
• Conditions: HIV in Adults
• Intervention / Treatment: Drug: Atazanavir; Drug: Cobicistat; Drug: Active Pharmaceutical Ingredient

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
      • Senopsys LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Men and women, ages ≥18 years
• Subjects who are qualified professional sensory panelists
• Healthy subjects as determined by no clinically significant deviation from normal in medical history and physical assessment

Exclusion Criteria:

• Any acute or chronic condition that may alter taste or smell sensory perception
• Any significant acute or chronic medical illness or any surgery within 4 weeks of the study drug administration
• Positive HIV test using an oral swab kit (such as OraQuick®) to detect HIV-1 or -2 antibody

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atazanavir and Cobicistat; Stage 1:Taste evaluation using Active Pharmaceutical Ingredient (API) Stage 2:Taste Optimization using API (flavours and sweeteners) Stage 3:Prototypes of the API - containing clinical trial materials	Drug: Atazanavir; Drug: Cobicistat; Drug: Active Pharmaceutical Ingredient; Other Names: (API)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria	Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria	Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria	Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria	Every 6 weeks from the time of subject enrollment up to 2 years
Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria	Every 6 weeks from the time of subject enrollment up to 2 years

Other Outcome Measures

Outcome Measure	Time Frame
Incident of adverse events will be tabulated and reviewed for potential significance and clinical important	Approximately up to 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2014
• Primary Completion (Actual): September 9, 2021
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Cobicistat; Atazanavir Sulfate
• Other Study ID Numbers: AI424-517

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No