Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male 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: BILR 355 BS (Drug); Tipranavir (Drug); Low dose of ritonavir (Drug); High dose of ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of
tipranavir/r on BILR 355 BS pharmacokinetics
Clinical Details
Official title: Study of Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the concentration-time curve of tipranavir and BILR 355 BS in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)
Secondary outcome: Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss)Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss) Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss) Apparent volume of distribution of BILR 355 BS, tipranavir and ritonavir during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss) Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h) Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss) Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss) Number of participants with clinically relevant changes in laboratory parameters Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate) Number of participants with clinically relevant changes in 12-lead ECG Number of participants with adverse events
Eligibility
Minimum age: 19 Years.
Maximum age: 59 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age ≥19 and <60 years
- BMI ≥18. 5 and BMI ≤29. 9 kg/m2
- Ability to give signed and dated written informed consent prior to admission to the
study in accordance with good clinical practice (GCP) and the local regulations
Exclusion Criteria:
- Current (symptomatic within the last 30 days) and medically relevant
gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Currently active (symptomatic within the last 30 days) diseases of the central
nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant
to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within one month prior to
administration of study drug or during the trial (review with clinical monitor if
questionable)
- Use of drugs within 10 days prior to administration or during the trial, which might
reasonably influence the results of the trial based on the knowledge at the time of
protocol preparation (review with clinical monitor if questionable)
- Participation in another trial with an investigational drug within one month prior to
administration or during the trial
- Current smoker or smoked within the past 30 days
- Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit
prescription or non-prescription drugs or drugs of abuse)
- Recent blood donation (more than 100 mL within 56 days prior to administration or
during the trial)
- Excessive physical activities (within 1 week prior to study drug administration or
during the trial)
- Any laboratory value outside the normal reference range that is of clinical relevance
at screening, according to the judgment of the investigator
- Inability to comply with dietary regimen required by the protocol
- Chronic or relevant acute infections
- Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B
surface antigen, or hepatitis C antibody positive)
- HIV-1 infected as defined by a positive HIV ELISA test
Locations and Contacts
Additional Information
Starting date: February 2005
Last updated: October 2, 2014
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