Clinical Trials

MainTitle

Taste Properties of Atazanavir and Cobicistat

This study is ongoing, but not recruiting participants.
Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT02307656

First received: October 29, 2014
Last updated: December 5, 2017
Last Verified: December 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV in Adults

Drug : Atazanavir
Drug : Cobicistat
Drug : Active Pharmaceutical Ingredient
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures

  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Every 6 weeks from the time of subject enrollment up to 2 years ]
Other Outcome Measures:
  • Incident of adverse events will be tabulated and reviewed for potential significance and clinical important [ Time Frame: Approximately up to 2 years ]

Estimated Enrollment: 6
Study Start Date: November 21, 2014
Estimated Study Completion Date: July 31, 2018
Estimated Primary Completion Date: July 30, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: (API)
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02307656

Locations

United States, Massachusetts
Senopsys Llc
Woburn, Massachusetts, United States, 01801

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

More Information

Additional Information:

BMS Clinical Trial Information

Additional Information:

FDA Safety Alerts and Recalls

Additional Information:

BMS Clinical Trial Patient Recruiting

Additional Information:

Investigator Inquiry Form

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT02307656   History of Changes  
Other Study ID Numbers: AI424-517  
Study First Received: October 29, 2014  
Last Updated: December 5, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Atazanavir Sulfate
Cobicistat

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.