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

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ClinicalTrials.gov Identifier: NCT02226978
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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
Healthy Drug: Tipranavir Drug: Ritonavir Drug: Valaciclovir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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



Primary Outcome Measures :
  1. Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12) [ Time Frame: up to 12 hours after drug administration ]
  2. Maximum measured concentration of aciclovir in plasma (Cmax) [ Time Frame: up to 12 hours after drug administration ]

Secondary Outcome Measures :
  1. AUC0-12 for Tipranavir (TPV) [ Time Frame: up to 12 hours after drug administration ]
  2. Cmax for TPV [ Time Frame: up to 12 hours after drug administration ]
  3. Drug concentration of TPV in plasma at 12 hours after administration (C12h) [ Time Frame: up to 12 hours after drug administration ]
  4. Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) [ Time Frame: up to 12 hours after drug administration ]
  5. Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) [ Time Frame: up to 12 hours after drug administration ]
  6. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: up to 12 hours after drug administration ]
  7. Number of subjects with adverse events [ Time Frame: up to 14 days after last drug administration ]
  8. Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 14 days after last drug administration ]
  9. AUC0-12 for Ritonavir (RTV) [ Time Frame: up to 12 hours after drug administration ]
  10. Cmax for RTV [ Time Frame: up to 12 hours after drug administration ]
  11. Drug concentration of RTV in plasma at 12 hours after administration (C12h) [ Time Frame: up to 12 hours after drug administration ]


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Ages Eligible for Study:   20 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02226978     History of Changes
Other Study ID Numbers: 1182.104
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Ritonavir
Tipranavir
Valacyclovir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors