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Completed

NCT Number: NCT00362726

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Hamilton, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Treatment and study plan

rosiglitazone maleate

Drug

Tablets, Oral, RGZ 4 mg, once daily, 1 day.

Atazanavir Sulphate

Drug

Capsules, Oral, ATV 400 mg, once daily, 5 days.

Other names: Reyataz

Atazanavir Sulphate + Rosiglitazone maleate

Drug

Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.

Other names: Reyataz

Atazanavir Sulphate + Ritonavir

Drug

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.

Other names: Reyataz

Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate

Drug

Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.

Other names: Reyataz

Primary outcomes

  1. 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 outcomes

  1. To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.

  2. To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Aug 10, 2006
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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