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Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Tipranavir (Drug); Ritonavir (Drug); Valaciclovir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV)

Clinical Details

Official title: An Open-label One-sequence Cross-over Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir 500/200 mg With Single-dose Valaciclovir (500 mg) in Healthy Volunteers

Study design: Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12)

Maximum measured concentration of aciclovir in plasma (Cmax)

Secondary outcome:

AUC0-12 for Tipranavir (TPV)

Cmax for TPV

Drug concentration of TPV in plasma at 12 hours after administration (C12h)

Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)

Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)

Terminal half-life of the analyte in plasma (t1/2)

Number of subjects with adverse events

Number of subjects with clinically significant findings in laboratory tests

AUC0-12 for Ritonavir (RTV)

Cmax for RTV

Drug concentration of RTV in plasma at 12 hours after administration (C12h)

Eligibility

Minimum age: 20 Years. Maximum age: 58 Years. Gender(s): Both.

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

- 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

- Age >19 and <59 years (20 - 58 years inclusive)

- Weight ≥ 60 kg

- Body mass index (BMI) >18. 5 and <29. 9 kg/m2

Exclusion Criteria:

- Any finding of the medical examination (including blood pressure, pulse rate, and

electrocardiogram) deviating from normal and of clinical relevance

- Atrioventricular (AV) block including 1°

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,

immunologic, hematological, oncological or hormonal disorders

- Surgery of gastrointestinal tract (except appendectomy)

- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or

neurological disorders

- Relevant history of orthostatic hypotension, fainting spells or blackouts

- Chronic or relevant acute infections

- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant

to the trial as judged by the investigator

- Known hypersensitivity to TPV, RTV, valaciclovir, aciclovir or antiretroviral drugs

(marketed or experimental use as part of clinical research studies)

- Known elevated liver enzymes in past trials with any compound

- Intake of drugs with a long half-life (>24 hours) (<1 month prior to administration)

- 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)

- Participation in another trial with an investigational drug (<2 months prior to

administration or expected during trial)

- Smoker with a consumption of >10 cigarettes or >3 cigars or >3 pipes/day and those

who cannot keep tobacco intake constant

- Alcohol (>40 g/day for males and >20 g/day for females) and drug abuse

- Blood donation or loss >400 mL, < 3 month prior to administration

- Clinically relevant laboratory abnormalities

- Transaminases above reference values in the history

- Inability to comply with dietary regimen of study centre

For female subjects:

- Pregnancy or planning to become pregnant within 60 days of study completion

- Positive pregnancy test

- 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

- 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

- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol

- Breast-feeding

Locations and Contacts

Additional Information

Starting date: February 2007
Last updated: August 26, 2014

Page last updated: August 23, 2015

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