Atazanavir Twice Daily

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357721
• Other study ID #: AI424-286
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2006
• Last updated: April 5, 2011
• Start date: June 2006
• Est. completion date: September 2006

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections
• Protease Inhibitor

Intervention

Drug:
• Atazanavir Sulphate
Capsules, Oral, 200 mg, twice daily, 7 days.
• Atazanavir Sulphate
Capsules, Oral, 300 mg, twice daily, 8 days.
• Atazanavir Sulphate
Capsules, Oral, 400 mg, twice daily, 9 days.

Locations

Country	Name	City	State
United States	Local Institution	Hamilton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.
Secondary	Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
Secondary	Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
Secondary	Assess the effect of atazanavir BID on metabolic parameters
Secondary	Assess the safety and tolerability of atazanavir when administered BID

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm