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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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Rosiglitazone maleate
Drug: Atazanavir Sulphate
Drug: Atazanavir Sulphate + Rosiglitazone maleate
Drug: Atazanavir Sulphate + Ritonavir
Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 14
Study Start Date: September 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Rosiglitazone maleate
Tablets, Oral, RGZ 4 mg, once daily, 1 day.
Active Comparator: B Drug: Atazanavir Sulphate
Capsules, Oral, ATV 400 mg, once daily, 5 days.
Other Name: Reyataz
Active Comparator: C Drug: Atazanavir Sulphate + Rosiglitazone maleate
Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
Other Name: Reyataz
Active Comparator: D Drug: Atazanavir Sulphate + Ritonavir
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
Other Name: Reyataz
Active Comparator: E 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362726

Locations
United States, New Jersey
Local Institution
Hamilton, New Jersey, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00362726     History of Changes
Other Study ID Numbers: AI424-106
Study First Received: August 9, 2006
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
Maleic acid
Ritonavir
Rosiglitazone
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014