Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00365339
First received: August 16, 2006
Last updated: April 7, 2011
Last verified: January 2009

August 16, 2006
April 7, 2011
April 2006
June 2006   (final data collection date for primary outcome measure)
Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
Same as current
Complete list of historical versions of study NCT00365339 on ClinicalTrials.gov Archive Site
Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.
Same as current
Not Provided
Not Provided
 
Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine 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+Ritonavir+Tenofovir
    Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
    Other Name: Abilify
  • Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
    Other Name: Abilify
  • Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
    Other Name: Abilify
  • Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
    Other Name: Abilify
  • Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
    Other Name: Abilify
  • Active Comparator: A
    Intervention: Drug: Atazanavir+Ritonavir+Tenofovir
  • Experimental: B
    Intervention: Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
  • Experimental: C
    Intervention: Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
  • Experimental: D
    Intervention: Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
  • Experimental: E
    Intervention: Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female subjects between the ages 18 to 50 years old with a 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
 
NCT00365339
AI424-287
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP