Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers
Study Details
Study Description
Brief Summary
Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TPV/r with valaciclovir VAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13) |
Drug: Tipranavir
Drug: Ritonavir
Drug: Valaciclovir
|
Outcome Measures
Primary Outcome Measures
- Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12) [up to 12 hours after drug administration]
- Maximum measured concentration of aciclovir in plasma (Cmax) [up to 12 hours after drug administration]
Secondary Outcome Measures
- AUC0-12 for Tipranavir (TPV) [up to 12 hours after drug administration]
- Cmax for TPV [up to 12 hours after drug administration]
- Drug concentration of TPV in plasma at 12 hours after administration (C12h) [up to 12 hours after drug administration]
- Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) [up to 12 hours after drug administration]
- Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) [up to 12 hours after drug administration]
- Terminal half-life of the analyte in plasma (t1/2) [up to 12 hours after drug administration]
- Number of subjects with adverse events [up to 14 days after last drug administration]
- Number of subjects with clinically significant findings in laboratory tests [up to 14 days after last drug administration]
- AUC0-12 for Ritonavir (RTV) [up to 12 hours after drug administration]
- Cmax for RTV [up to 12 hours after drug administration]
- Drug concentration of RTV in plasma at 12 hours after administration (C12h) [up to 12 hours after drug administration]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male and non-pregnant, non-lactating female subjects as determined by results of screening
-
Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
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The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and willingness to comply with all study requirements
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Age >19 and <59 years (20 - 58 years inclusive)
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Weight ≥ 60 kg
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Body mass index (BMI) >18.5 and <29.9 kg/m2
Exclusion Criteria:
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Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
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Atrioventricular (AV) block including 1°
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Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological or hormonal disorders
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Surgery of gastrointestinal tract (except appendectomy)
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Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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Relevant history of orthostatic hypotension, fainting spells or blackouts
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Chronic or relevant acute infections
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History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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Known hypersensitivity to TPV, RTV, valaciclovir, aciclovir or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
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Known elevated liver enzymes in past trials with any compound
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Intake of drugs with a long half-life (>24 hours) (<1 month prior to administration)
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Prescription or over the counter medications (including vitamins, minerals, herbal supplements and antacids), dietary supplements 14 days prior to study drug administration or expected during the trial)
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Participation in another trial with an investigational drug (<2 months prior to administration or expected during trial)
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Smoker with a consumption of >10 cigarettes or >3 cigars or >3 pipes/day and those who cannot keep tobacco intake constant
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Alcohol (>40 g/day for males and >20 g/day for females) and drug abuse
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Blood donation or loss >400 mL, < 3 month prior to administration
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Clinically relevant laboratory abnormalities
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Transaminases above reference values in the history
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Inability to comply with dietary regimen of study centre
For female subjects:
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Pregnancy or planning to become pregnant within 60 days of study completion
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Positive pregnancy test
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Have not been using a barrier method of contraception for at least 3 months prior to participation in the study if of childbearing potential and not surgically sterilized
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Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial if of childbearing potential and not surgically sterilized
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Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
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Breast-feeding
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1182.104