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
Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atazanavir
Intervention: atazanavir (Drug); Atazanavir(ATZ) and Tenofovir(TDF) (Drug); Atazanavir(ATZ) + Ritonavir (Drug); atazanavir(ATZ) + tenofovir(TDF) + ritonavir (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Asan Medical Center Overall contact: Kyun-Seop Bae, M.D., Ph. D., Phone: 82-2-3010-4622
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Pharmacokinetic analysis
Secondary outcome: Pharmacokinetic evaluation
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Male.
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
Locations and Contacts
Kyun-Seop Bae, M.D., Ph. D., Phone: 82-2-3010-4622
Asan Medical Center, Songpa-gu, Seoul 138-736, Korea, Republic of; Not yet recruiting Kyun-Seop Bae, M.D., Ph. D., Phone: 82-2-3010-4622
Additional Information
Starting date: June 2011
Last updated: June 7, 2011
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