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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 Criteria

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

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

Page last updated: August 23, 2015

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