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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Acyclovir; Ritonavir; Tipranavir; Valacyclovir

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