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Clinical Trials/NCT00357721
NCT00357721
Completed
Phase 1

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

Bristol-Myers Squibb1 site in 1 country18 target enrollmentJune 2006
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ConditionsHIV InfectionsProtease Inhibitor
InterventionsAtazanavir Sulphate
DrugsAtazanavir Sulphate

Overview

Phase
Phase 1
Intervention
Atazanavir Sulphate
Conditions
HIV Infections
Sponsor
Bristol-Myers Squibb
Enrollment
18
Locations
1
Primary Endpoint
Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
September 2006
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

A1

Intervention: Atazanavir Sulphate

A2

Intervention: Atazanavir Sulphate

A3

Intervention: Atazanavir Sulphate

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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

Study Sites (1)

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