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Protease Inhibitor

Treatment Sequence Group 1 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/[height(m)]^2
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 75 days
Awards & highlights

Study Summary

The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.

Eligible Conditions
  • Healthy Subjects

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 75 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 75 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
Apparent terminal plasma half-life (T-HALF)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Changes in Taste Evaluation Questionnaire
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment Sequence Group 3Experimental Treatment3 Interventions
Group II: Treatment Sequence Group 2Experimental Treatment3 Interventions
Group III: Treatment Sequence Group 1Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobicistat
2014
Completed Phase 2
~640
Atazanavir/Cobicistat Mini-tablet
2022
Completed Phase 1
~50
Atazanavir
2014
Completed Phase 4
~8310

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,640 Previous Clinical Trials
4,129,422 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions
2022. "A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05236738.
~14 spots leftby Apr 2025
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