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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 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
  Purpose

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
Atazanavir
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
Endpoint Classification: Safety/Efficacy Study
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 [ Designated as safety issue: Yes ]
    maximum concentration at steady status(Cmax,ss)


Secondary Outcome Measures:
  • Pharmacokinetic evaluation [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01368783     History of Changes
Other Study ID Numbers: 2011-ATV
Study First Received: June 7, 2011
Last Updated: June 7, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Atazanavir
Ritonavir
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014