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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atazanavir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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atazanavir

400 mg/day for 2 days

ATZ 400 mg with TDF/day for 2 days

Intervention Type DRUG

Atazanavir(ATZ) + Ritonavir

ATZ 300 mg + Ritonavir 100 mg/day for 2 days

Intervention Type DRUG

atazanavir(ATZ) + tenofovir(TDF) + ritonavir

ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes