Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

June 21, 2011 updated by: Avexa

A Phase I, Open Label, Controlled, Intra-subject Comparison Study to Investigate the Effect of Co-administration Upon the Pharmacokinetics of Tipranavir (Ritonavir Boosted) and Apricitabine.

The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. Also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. Information on the safety and tolerability of the two drugs when dosed together will also be obtained.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Jasper Clinic Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy males 18-40 years old
  • non-smokers
  • no clinically significant medical history

Exclusion Criteria:

  • current or relevant previous medical history of significance
  • hepatitis B, hepatitis C, or HIV positive
  • current use of prescription or OTC medications
  • use of illicit substances or alcohol (>14 drinks/week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily.
Time Frame: day 1 and day 10
day 1 and day 10

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine.
Time Frame: day 9 and day 10
day 9 and day 10
To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.
Time Frame: day 10
day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avexa

Investigators

  • Study Director: Susan W Cox, Ph D, Avexa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVX-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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