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

July 25, 2006
April 7, 2011
June 2006
August 2006   (final data collection date for primary outcome measure)
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
Same as current
Complete list of historical versions of study NCT00357240 on ClinicalTrials.gov Archive Site
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
Same as current
Not Provided
Not Provided
 
Drug Interaction Study With Proton Pump Inhibitor
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: Atazanavir
    Capsules, Oral, 400 mg, once daily, 6 days.
    Other Name: Reyataz
  • Drug: Atazanavir/Ritonavir
    Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
    Other Name: Reyataz
  • 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
  • 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
  • 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
  • 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
  • Active Comparator: A1
    Intervention: Drug: Atazanavir
  • Active Comparator: A2
    Intervention: Drug: Atazanavir/Ritonavir
  • Experimental: A3 I
    Intervention: Drug: Atazanavir/Ritonavir+Omeprazole
  • Experimental: A3 II
    Intervention: Drug: Atazanavir/Ritonavir+Omeprazole
  • Active Comparator: B1
    Intervention: Drug: Atazanavir
  • Active Comparator: B2
    Intervention: Drug: Atazanavir/Ritonavir
  • Experimental: B3 I
    Intervention: Drug: Atazanavir/Ritonavir+Omeprazole
  • Experimental: B3 II
    Intervention: Drug: Atazanavir/Ritonavir+Omeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
August 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 18 to 50 years old with 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
 
NCT00357240
AI424-288
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