Atazanavir Twice Daily

Phase 1

Completed

• Conditions: HIV Infections; Protease Inhibitor
• Interventions: Drug: Atazanavir Sulphate

• Registration Number: NCT00357721
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-05
• Last Update Posted: 2011-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A3	Atazanavir Sulphate	-
A1	Atazanavir Sulphate	-
A2	Atazanavir Sulphate	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Hamilton, New Jersey, United States