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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Asan Medical Center.
Recruitment status was:  Not yet recruiting
Bristol-Myers Squibb
Information provided by:
Asan Medical Center Identifier:
First received: June 7, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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 Intervention Phase
Drug: atazanavir
Drug: Atazanavir(ATZ) and Tenofovir(TDF)
Drug: Atazanavir(ATZ) + Ritonavir
Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

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

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

Estimated Enrollment: 32
Study Start Date: June 2011
Arms Assigned Interventions
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


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

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
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Please refer to this study by its identifier: NCT01368783

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

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 Identifier: NCT01368783     History of Changes
Other Study ID Numbers: 2011-ATV
Study First Received: June 7, 2011
Last Updated: June 7, 2011

Additional relevant MeSH terms:
Atazanavir Sulfate
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on April 25, 2017