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Drug Interaction Study With Proton Pump Inhibitor

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00357240
First received: July 25, 2006
Last updated: April 7, 2011
Last verified: June 2008
History of Changes
  Purpose

The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.


Condition Intervention Phase
HIV Infections
 Drug: Atazanavir
Drug: Atazanavir/Ritonavir
Drug: Atazanavir/Ritonavir+Omeprazole
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.

Secondary Outcome Measures:
  • PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.

Estimated Enrollment: 56
Study Start Date: June 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Atazanavir
Capsules, Oral, 400 mg, once daily, 6 days.
Other Name: Reyataz
Active Comparator: A2 Drug: Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Other Name: Reyataz
Experimental: A3 I Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
Other Name: Reyataz
Experimental: A3 II Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
Other Name: Reyataz
Active Comparator: B1 Drug: Atazanavir
Capsules, Oral, 400 mg, once daily, 6 days.
Other Name: Reyataz
Active Comparator: B2 Drug: Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
Other Name: Reyataz
Experimental: B3 I Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.
Other Name: Reyataz
Experimental: B3 II Drug: Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.
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 of 18 to 50 years old with BMI 18 to 32 kg/m2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357240

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:
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

ClinicalTrials.gov Identifier: NCT00357240     History of Changes
Other Study ID Numbers: AI424-288
Study First Received: July 25, 2006
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Protease inhibitor

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Omeprazole
Ritonavir
Atazanavir
 Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013