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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: apricitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Avexa:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: July 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352066

Locations
United States, Michigan
Jasper Clinic Inc
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Avexa
Investigators
Study Director: Susan W Cox, Ph D Avexa
  More Information

No publications provided

Responsible Party: Susan Cox, Avexa
ClinicalTrials.gov Identifier: NCT00352066     History of Changes
Other Study ID Numbers: AVX-102
Study First Received: July 12, 2006
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Avexa:
Human Immunodeficiency Virus
anti-retroviral therapy
nucleoside analogue
reverse transcriptase
apricitabine
tipranavir
bioequivalence
drug-drug interaction
pharmacokinetics

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014