Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00362726

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 I

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Rosiglitazone Rosiglitazone Maleate Ritonavir BMS 232632 Atazanavir sulfate

U.S. FDA Resources

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

Arms	Assigned Interventions
A: Active Comparator	Drug: Rosiglitazone maleate Tablets, Oral, RGZ 4 mg, once daily, 1 day.
B: Active Comparator	Drug: Atazanavir Sulphate Capsules, Oral, ATV 400 mg, once daily, 5 days.
C: Active Comparator	Drug: Atazanavir Sulphate + Rosiglitazone maleate Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
D: Active Comparator	Drug: Atazanavir Sulphate + Ritonavir Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
E: Active Comparator	Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.

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

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	AI424-106
Study First Received:	August 9, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00362726 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV

Study placed in the following topic categories:

Anti-Infective Agents
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Healthy
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors

Virus Diseases
Hypoglycemic Agents
Anti-Retroviral Agents
HIV Infections
Ritonavir
Maleic acid
Sexually Transmitted Diseases
Retroviridae Infections
Rosiglitazone

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Infection
Hypoglycemic Agents
Anti-Retroviral Agents
Maleic acid
Therapeutic Uses
Retroviridae Infections
Rosiglitazone
RNA Virus Infections
HIV Protease Inhibitors

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on September 02, 2009