Healthy
Conditions
Brief summary
Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS
Interventions
DRUGBILR 355 BS
DRUGPEG 400
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
All participants in the study should be healthy males, ranging 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 will have given 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 |
|---|---|
| Number of participants with clinically significant changes in vital functions | Up to 10 days after drug administration |
| Number of participants with abnormal findings in ECG (electrocardiogram) | Up to 10 days after drug administration |
| Number of participants with abnormal findings in skin inspections | Up to 10 days after drug administration |
| Number of participants with abnormal neurological finding | Up to 10 days after drug administration |
| Number of participants with abnormal changes in laboratory parameters | Up to 10 days after drug administration |
| Number of participants with positive faecal occult blood testing | Up to 10 days after drug administration |
| Number of participants with adverse events | Up to 10 days after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Renal clearance of the analyte (CLR) | Up to 72 hours after drug administration |
| Maximum plasma concentration (Cmax) | Up to 144 hours after drug administration |
| Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz) | Up to 144 hours after drug administration |
| Amount of drug excreted in the urine (Ae) | Up to 72 hours after drug administration |
| Time to attain maximum plasma concentration (tmax) | Up to 144 hours after drug administration |
| Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞) | Up to 144 hours after drug administration |
| Terminal half life (t½) | Up to 144 hours after drug administration |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | Up to 144 hours after drug administration |
| Total mean residence time (MRTtot) | Up to 144 hours after drug administration |
| Apparent volume of distribution during the terminal elimination phase (Vz/F) | Up to 144 hours after drug administration |
Outcome results
None listed