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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368783

Enrollment

Registered

2011-06-08

Start date

2011-06-30

Completion date

Unknown

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atazanavir

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.

Interventions

DRUGatazanavir

400 mg/day for 2 days

DRUGAtazanavir(ATZ) and Tenofovir(TDF)

ATZ 400 mg with TDF/day for 2 days

DRUGAtazanavir(ATZ) + Ritonavir

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

DRUGatazanavir(ATZ) + tenofovir(TDF) + ritonavir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic analysis	—	maximum concentration at steady status(Cmax,ss)

Secondary

Measure	Time frame	Description
Pharmacokinetic evaluation	—	Area under the time-concentration curve, at steady status, at tau(τ) (AUCτ,ss)

Countries

South Korea

Contacts

Primary ContactKyun-Seop Bae, M.D., Ph. D.

82-2-3010-4622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026