Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: apricitabine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: apricitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | day 1 and day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | day 9 and day 10 | 
| To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir. |  | day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, apricitabine, tipranavir, bioequivalence, drug-drug interaction, pharmacokinetics