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

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.

Study Overview

• Status: Unknown
• Conditions: Atazanavir
• Intervention / Treatment: Drug: atazanavir; Drug: Atazanavir(ATZ) and Tenofovir(TDF); Drug: Atazanavir(ATZ) + Ritonavir; Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Songpa-gu, Seoul, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: atazanavir; 400 mg/day for 2 days	Drug: atazanavir; 400 mg/day for 2 days
Experimental: Atazanavir and Tenofovir	Drug: Atazanavir(ATZ) and Tenofovir(TDF); ATZ 400 mg with TDF/day for 2 days
Experimental: Atazanavir and Ritonavir	Drug: Atazanavir(ATZ) + Ritonavir; ATZ 300 mg + Ritonavir 100 mg/day for 2 days
Experimental: Atazanavir + tenofovir + ritonavir	Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir; ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Pharmacokinetic analysis	maximum concentration at steady status(Cmax,ss)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: June 1, 2011

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Ritonavir; Atazanavir Sulfate
• Other Study ID Numbers: 2011-ATV