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

Asan Medical Center

Status and phase: Unknown; Phase 1

Conditions: Atazanavir

Treatments: Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir; Drug: Atazanavir(ATZ) and Tenofovir(TDF); Drug: Atazanavir(ATZ) + Ritonavir; Drug: atazanavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01368783

2011-ATV

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

atazanavir

Experimental group

Description:

400 mg/day for 2 days

Treatment:

Drug: atazanavir

Atazanavir and Tenofovir

Experimental group

Treatment:

Drug: Atazanavir(ATZ) and Tenofovir(TDF)

Atazanavir and Ritonavir

Experimental group

Treatment:

Drug: Atazanavir(ATZ) + Ritonavir

Atazanavir + tenofovir + ritonavir

Experimental group

Treatment:

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