Healthy
Conditions
Brief summary
Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* All participants in the study were to be healthy males, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters) * In accordance with good clinical practice (GCP) and the local legislation all volunteers had to give their written informed consent prior to admission to the study
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * 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 * Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study * Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study * Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial) * Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (\>= 100 mL within four weeks prior to administration or during the trial) * Any laboratory value outside the clinically accepted reference range * Excessive physical activities within the last week before the trial or during the trial Following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of the analyte excreted into urine (Ae) | up to 72 hours after start of treatment |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | up to 120 hours after start of treatment |
| Area under the concentration-time curve of the analyte in plasma at different time points (AUC) | up to 120 hours after start of treatment |
| Apparent terminal half-life of the analyte in plasma (t1/2) | up to 120 hours after start of treatment |
| Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/F) | up to 120 hours after start of treatment |
| Total mean residence time of the analyte in the body (MRTtot) | up to 120 hours after start of treatment |
| Apparent volume of distribution of the analyte during the terminal phase λz following extravascular administration (Vz/F) | up to 120 hours after start of treatment |
| Renal clearance of the analyte determined over the dosing interval τ (CLR) | up to 120 hours after start of treatment |
| Maximum observed concentration of the analyte in the plasma (Cmax) | up to 120 hours after start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically relevant changes in vital signs (blood pressure, pulse-, respiratory rate, body temperature) | up to 10 days after start of treatment | — |
| Number of participants with clinically relevant changes in 12-lead ECG | up to 10 days after start of treatment | — |
| Number of participants with clinically relevant changes in faecal occult blood testing | up to 10 days after start of treatment | — |
| Number of participants with adverse events | Up to 25 days | — |
| Global tolerability assessment by investigator on a 5-point scale | Up to 10 days after start of treatment | — |
| Number of participants with clinically relevant changes in neurological assessment | up to 10 days after start of treatment | Assessment of central nervous system function including Romberg's test, heel-to-toe straight line, and finger-nose tests |
| Number of participants with clinically relevant changes in laboratory parameters | up to 10 days after start of treatment | — |
Outcome results
None listed