Healthy
Conditions
Brief summary
To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females who meet the inclusion/
Exclusion criteria
; females must not be pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives) 2. Age ≥18 and \<60 years 3. BMI ≥18.5 and BMI ≤29.9 kg/m2 4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss) | Up to 12 h after the last drug administration of BILR 355 |
| Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss) | Up to 96 h after the last drug administration of BILR 355 |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | Up to 96 h after the last drug administration of BILR 355 |
| Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss) | Up to 96 h after the last drug administration of BILR 355 |
| Area under the plasma concentration time curve (0-12 hours) (AUC0-12h) for RTV | Up to 12 h after RTV administration |
| Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for RTV | Up to 96 h after the last drug administration of BILR 355 |
| Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss) | Up to 96 h after the last drug administration of BILR 355 |
| Number of participants with Adverse Events | Up to day 35 after first drug administration |
| Number of participants with abnormal changes in clinical laboratory parameters | Up to day 35 after first drug administration |
| Number of participants with abnormal findings in physical examination | Up to day 35 after first drug administration |
| Number of participants with clinically significant changes in vital signs | Up to day 35 after first drug administration |
| Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h,ss) | Up to 12 h after the last drug administration of BILR 355 |
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | Up to 96 h after the last drug administration of BILR 355 |
Outcome results
None listed