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

NCT02226978 | Completed Phase 1

• 1 other identifier: 1182.104
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (1)

TPV/r with valaciclovir

EXPERIMENTAL

VAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13)

Drug: Tipranavir; Drug: Ritonavir; Drug: Valaciclovir

Interventions

Tipranavir DRUG

TPV/r with valaciclovir

Ritonavir DRUG

TPV/r with valaciclovir

Valaciclovir DRUG

TPV/r with valaciclovir

Eligibility Criteria

• Age: 20 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

tipranavir; Ritonavir; Valacyclovir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: February 1, 2007
• Primary Completion: May 1, 2007
• Last Updated: August 27, 2014

Record last verified: 2014-08