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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

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ClinicalTrials.gov Identifier: NCT01368783
Recruitment Status : Unknown
Verified May 2011 by Asan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2011
Last Update Posted : June 8, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atazanavir Drug: atazanavir Drug: Atazanavir(ATZ) and Tenofovir(TDF) Drug: Atazanavir(ATZ) + Ritonavir Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: atazanavir
400 mg/day for 2 days
Drug: atazanavir
400 mg/day for 2 days
Experimental: Atazanavir and Tenofovir Drug: Atazanavir(ATZ) and Tenofovir(TDF)
ATZ 400 mg with TDF/day for 2 days
Experimental: Atazanavir and Ritonavir Drug: Atazanavir(ATZ) + Ritonavir
ATZ 300 mg + Ritonavir 100 mg/day for 2 days
Experimental: Atazanavir + tenofovir + ritonavir Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir
ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetic analysis
    maximum concentration at steady status(Cmax,ss)


Secondary Outcome Measures :
  1. Pharmacokinetic evaluation
    Area under the time-concentration curve, at steady status, at tau(τ) (AUCτ,ss)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368783


Contacts
Contact: Kyun-Seop Bae, M.D., Ph. D. 82-2-3010-4622

Locations
Korea, Republic of
Asan Medical Center Not yet recruiting
Songpa-gu, Seoul, Korea, Republic of, 138-736
Contact: Kyun-Seop Bae, M.D., Ph. D.    82-2-3010-4622      
Sponsors and Collaborators
Asan Medical Center
Bristol-Myers Squibb
More Information

ClinicalTrials.gov Identifier: NCT01368783     History of Changes
Other Study ID Numbers: 2011-ATV
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Ritonavir
Atazanavir Sulfate
Tenofovir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors