Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
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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. |
- 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 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) |
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 |
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 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 May 22, 2013