Taste Properties of Atazanavir and Cobicistat

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-12

Study Completion Date

2021-09-09

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV in Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Atazanavir

Intervention Type DRUG

Cobicistat

Intervention Type DRUG

Active Pharmaceutical Ingredient

Intervention Type DRUG

Interventions

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Atazanavir

Intervention Type DRUG

Cobicistat

Intervention Type DRUG

Active Pharmaceutical Ingredient

Intervention Type DRUG

Other Intervention Names

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(API)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes