Skip to main content
OpenTrials
Completed

NCT Number: NCT02307656

Taste Properties of Atazanavir and Cobicistat

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV in Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Senopsys Llc

Woburn, Massachusetts, 01801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atazanavir

Drug

Cobicistat

Drug

Active Pharmaceutical Ingredient

Drug

Other names: (API)

Primary outcomes

  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 outcomes

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

    Time frame: Approximately up to 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2014
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.