Clinical trial NCT02257021: Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers
Official title: Study of Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 34
Sex: MALE
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of tipranavir/r on BILR 355 BS pharmacokinetics


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: up to 18 days after start of treatment
measure: Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)
timeFrame: up to 18 days after start of treatment
Secondary outcomes:
measure: Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss)
timeFrame: up to 18 days after start of treatment
measure: Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss)
timeFrame: up to 18 days after start of treatment
measure: Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss)
timeFrame: up to 18 days after start of treatment
measure: 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)
timeFrame: up to 18 days after start of treatment
measure: Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h)
timeFrame: up to 18 days after start of treatment
measure: Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss)
timeFrame: up to 18 days after start of treatment
measure: Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss)
timeFrame: up to 18 days after start of treatment
measure: Number of participants with clinically relevant changes in laboratory parameters
timeFrame: up to 28 days after start of treatment
measure: Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate)
timeFrame: up to 28 days after start of treatment
measure: Number of participants with clinically relevant changes in 12-lead ECG
timeFrame: up to 14 days after start of treatment
measure: Number of participants with adverse events
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
Study officials:
References: