Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together

This study has been completed.
Sponsor:
Information provided by:
Avexa
ClinicalTrials.gov Identifier:
NCT00352066
First received: July 12, 2006
Last updated: June 21, 2011
Last verified: June 2011

July 12, 2006
June 21, 2011
July 2006
August 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT00352066 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir. [ Time Frame: day 10 ] [ Designated as safety issue: Yes ]
  • To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine.
  • To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.
Not Provided
Not Provided
 
Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV Infection
Drug: apricitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2006
August 2006   (final data collection date for primary outcome measure)

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)
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00352066
AVX-102
No
Susan Cox, Avexa
Avexa
Not Provided
Study Director: Susan W Cox, Ph D Avexa
Avexa
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP