DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017