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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

Tracking Information
First Submitted Date  ICMJE August 26, 2014
First Posted Date  ICMJE August 27, 2014
Last Update Posted Date August 27, 2014
Study Start Date  ICMJE February 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
  • 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 ]
  • Maximum measured concentration of aciclovir in plasma (Cmax) [ Time Frame: up to 12 hours after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
  • AUC0-12 for Tipranavir (TPV) [ Time Frame: up to 12 hours after drug administration ]
  • Cmax for TPV [ Time Frame: up to 12 hours after drug administration ]
  • Drug concentration of TPV in plasma at 12 hours after administration (C12h) [ Time Frame: up to 12 hours after drug administration ]
  • Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) [ Time Frame: up to 12 hours after drug administration ]
  • Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) [ Time Frame: up to 12 hours after drug administration ]
  • Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: up to 12 hours after drug administration ]
  • Number of subjects with adverse events [ Time Frame: up to 14 days after last drug administration ]
  • Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 14 days after last drug administration ]
  • AUC0-12 for Ritonavir (RTV) [ Time Frame: up to 12 hours after drug administration ]
  • Cmax for RTV [ Time Frame: up to 12 hours after drug administration ]
  • Drug concentration of RTV in plasma at 12 hours after administration (C12h) [ Time Frame: up to 12 hours after drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Tipranavir
  • Drug: Ritonavir
  • Drug: Valaciclovir
Study Arms  ICMJE Experimental: TPV/r with valaciclovir
VAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13)
Interventions:
  • Drug: Tipranavir
  • Drug: Ritonavir
  • Drug: Valaciclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2014)
29
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02226978
Other Study ID Numbers  ICMJE 1182.104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP