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Taste Properties of Atazanavir and Cobicistat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307656
Recruitment Status : Unknown
Verified June 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
HIV in Adults Drug: Atazanavir Drug: Cobicistat Drug: Active Pharmaceutical Ingredient Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
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
Actual Study Start Date : November 21, 2014
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : April 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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:
  1. Incident of adverse events will be tabulated and reviewed for potential significance and clinical important [ Time Frame: Approximately up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307656


Locations
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United States, Massachusetts
Senopsys Llc
Woburn, Massachusetts, United States, 01801
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02307656    
Other Study ID Numbers: AI424-517
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atazanavir Sulfate
Cobicistat
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors