Taste Properties of Atazanavir and Cobicistat
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV (Adult)
Intervention: Atazanavir (Drug); Cobicistat (Drug); Active Pharmaceutical Ingredient (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Overall contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com
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.
Clinical Details
Official title: Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults
Study design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: 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 CriteriaTaste 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 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 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 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com
Senopsys Llc, Woburn, Massachusetts 01801, United States; Recruiting Gary Connor, Site 0001, Phone: 781-935-7450
Additional Information
BMS Clinical Trial Information BMS clinical trial educational resource Investigator Inquiry form FDA Safety Alerts and Recalls
Starting date: November 2014
Last updated: July 3, 2015
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