Taste Properties of Atazanavir and Cobicistat

NCT02307656 | Completed Phase 1 FDA Drug

• 1 other identifier: AI424-517
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV in Adults

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Incident of adverse events will be tabulated and reviewed for potential significance and clinical important

  Approximately up to 2 years

Study Arms (1)

Atazanavir and Cobicistat

OTHER

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

Interventions

Atazanavir DRUG

Atazanavir and Cobicistat

Cobicistat DRUG

Atazanavir and Cobicistat

Active Pharmaceutical Ingredient DRUG

Also known as: (API)

Atazanavir and Cobicistat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Senopsys Llc

Woburn, Massachusetts, 01801, United States

Location

Related Links

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

MeSH Terms

Interventions

Atazanavir Sulfate; Cobicistat

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: December 4, 2014
• Study Start: December 12, 2014
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Locations

US (1)