Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00362726
First received: August 9, 2006
Last updated: April 7, 2011
Last verified: June 2008

August 9, 2006
April 7, 2011
September 2006
November 2006   (final data collection date for primary outcome measure)
To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
Same as current
Complete list of historical versions of study NCT00362726 on ClinicalTrials.gov Archive Site
  • To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
  • To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
  • To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
  • To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure.
Not Provided
Not Provided
 
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects

The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
HIV Infections
  • Drug: Rosiglitazone maleate
    Tablets, Oral, RGZ 4 mg, once daily, 1 day.
  • Drug: Atazanavir Sulphate
    Capsules, Oral, ATV 400 mg, once daily, 5 days.
    Other Name: Reyataz
  • Drug: Atazanavir Sulphate + Rosiglitazone maleate
    Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
    Other Name: Reyataz
  • Drug: Atazanavir Sulphate + Ritonavir
    Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
    Other Name: Reyataz
  • Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate
    Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
    Other Name: Reyataz
  • Active Comparator: A
    Intervention: Drug: Rosiglitazone maleate
  • Active Comparator: B
    Intervention: Drug: Atazanavir Sulphate
  • Active Comparator: C
    Intervention: Drug: Atazanavir Sulphate + Rosiglitazone maleate
  • Active Comparator: D
    Intervention: Drug: Atazanavir Sulphate + Ritonavir
  • Active Comparator: E
    Intervention: Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00362726
AI424-106
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP