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Status unknownNCT01368783Updated Jun 8, 2011

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

A Phase 1 interventional study of atazanavir and Atazanavir(ATZ) and Tenofovir(TDF) in Atazanavir, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-08.

Sponsored by Asan Medical Center · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Atazanavir
03

In context

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    atazanavir

    400 mg/day for 2 days

    Drug: atazanavir

  • Experimental
    Atazanavir and Tenofovir

    Drug: Atazanavir(ATZ) and Tenofovir(TDF)

  • Experimental
    Atazanavir and Ritonavir

    Drug: Atazanavir(ATZ) + Ritonavir

  • Experimental
    Atazanavir + tenofovir + ritonavir

    Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir

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

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic analysis

    maximum concentration at steady status(Cmax,ss)

Secondary outcomes

  1. Pharmacokinetic evaluation

    Area under the time-concentration curve, at steady status, at tau(τ) (AUCτ,ss)

07

Study locations

1 site
  • Asan Medical Center
    Songpa-gu, Seoul 138-736, Korea, Republic of
    • Kyun-Seop Bae, M.D., Ph. D. · Contact · 82-2-3010-4622
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01368783
Lead sponsor
Asan Medical Center
Collaborators
Bristol-Myers Squibb
First posted
Jun 8, 2011
Start date
Jun 2011
Last update
Jun 8, 2011

Study contacts

Kyun-Seop Bae, M.D., Ph. D.
Contact
82-2-3010-4622
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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