Two Clinical Trials to Evaluate Pharmacokinetics of Unboosted and Boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Asan Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01368783
First received: June 7, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted

June 7, 2011
June 7, 2011
June 2011
Not Provided
Pharmacokinetic analysis [ Designated as safety issue: Yes ]
maximum concentration at steady status(Cmax,ss)
Same as current
No Changes Posted
Pharmacokinetic evaluation [ Designated as safety issue: Yes ]
Area under the time-concentration curve, at steady status, at tau(τ) (AUCτ,ss)
Same as current
Not Provided
Not Provided
 
Two Clinical Trials to Evaluate Pharmacokinetics of Unboosted and Boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers
Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and Caucasian volunteers and compare the ethnic differences.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Atazanavir
  • Drug: atazanavir
    400 mg/day for 2 days
  • Drug: Atazanavir(ATZ) and Tenofovir(TDF)
    ATZ 400 mg with TDF/day for 2 days
  • Drug: Atazanavir(ATZ) + Ritonavir
    ATZ 300 mg + Ritonavir 100 mg/day for 2 days
  • Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir
    ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days
  • Experimental: atazanavir
    400 mg/day for 2 days
    Intervention: Drug: atazanavir
  • Experimental: Atazanavir and Tenofovir
    Intervention: Drug: Atazanavir(ATZ) and Tenofovir(TDF)
  • Experimental: Atazanavir and Ritonavir
    Intervention: Drug: Atazanavir(ATZ) + Ritonavir
  • Experimental: Atazanavir + tenofovir + ritonavir
    Intervention: Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
32
Not Provided
Not Provided

Inclusion Criteria:

  • Men aged 20 to 55 years old, with a weight more than 50 kg and with appropriate body mass index (BMI) values within 19-28 kg/m2.
  • Agreed voluntarily to participate to the study and comply with the study protocol with written permission.

Exclusion Criteria:

  • Has history of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
  • Has history of hypersensitivity or clinically significant adverse drug reaction(s) to the study drugs, same class of the study drugs, or other drugs including aspirin and antibiotics.
  • Drinks excessive caffeinated beverages (caffeine >10 units/day), alcohol beverages (alcohol >21 units/week) or smokes excessively (>20 cigarettes/day) or has history of alcoholism.
  • Has been excluded by the researchers due to abnormal findings in screening EKG and/or blood tests
Male
20 Years to 55 Years
Yes
Contact: Kyun-Seop Bae, M.D., Ph. D. 82-2-3010-4622
Korea, Republic of
 
NCT01368783
2011-ATV
Not Provided
Not Provided
Asan Medical Center
Bristol-Myers Squibb
Not Provided
Asan Medical Center
May 2011

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