Atazanavir Twice Daily

April 5, 2011 updated by: Bristol-Myers Squibb

Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hamilton, New Jersey, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1
Drug: Atazanavir Sulphate
Capsules, Oral, 200 mg, twice daily, 7 days.
Other Names:
  • Reyataz
Drug: Atazanavir Sulphate
Capsules, Oral, 300 mg, twice daily, 8 days.
Other Names:
  • Reyataz
Drug: Atazanavir Sulphate
Capsules, Oral, 400 mg, twice daily, 9 days.
Other Names:
  • Reyataz
Active Comparator: A2
Drug: Atazanavir Sulphate
Capsules, Oral, 200 mg, twice daily, 7 days.
Other Names:
  • Reyataz
Drug: Atazanavir Sulphate
Capsules, Oral, 300 mg, twice daily, 8 days.
Other Names:
  • Reyataz
Drug: Atazanavir Sulphate
Capsules, Oral, 400 mg, twice daily, 9 days.
Other Names:
  • Reyataz
Active Comparator: A3
Drug: Atazanavir Sulphate
Capsules, Oral, 200 mg, twice daily, 7 days.
Other Names:
  • Reyataz
Drug: Atazanavir Sulphate
Capsules, Oral, 300 mg, twice daily, 8 days.
Other Names:
  • Reyataz
Drug: Atazanavir Sulphate
Capsules, Oral, 400 mg, twice daily, 9 days.
Other Names:
  • Reyataz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.

Secondary Outcome Measures

Outcome Measure
Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
Assess the effect of atazanavir BID on metabolic parameters
Assess the safety and tolerability of atazanavir when administered BID

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI424-286

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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