Healthy
Conditions
Brief summary
The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (steady state and accumulation factor)
Interventions
DRUGBIIF 1149 BS - single rising dose
DRUGPlacebo
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
* Participants should be healthy males * Age range from 21 to 50 years * Within +- 20% of their normal weight (Broca-Index) * In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study * Each subject will have his medical history taken and will receive a complete medical examination (incl. demographics, medical history, check of inclusion/
Exclusion criteria
, physical examination, vital signs, 12-lead Electrocardiogram (ECG) * Haematopoietic, hepatic and renal function test will be carried out in the laboratory * The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | up to 55 days |
| Number of subjects with abnormal changes in laboratory parameters | up to 8 days after last blood sample |
| Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) | up to 8 days after last blood sample |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area under the concentration-time curve of the analyte in plasma) | up to 360 hours after last drug administration |
| Ae (Urinary excretion of parent drug) | up to 120 hours after last drug administration |
| Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | after 24 hours of drug administration on day 9 |
| MRT (Mean residence time of the analyte in the body) | up to 360 hours after last drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 360 hours after last drug administration |
| Cmax (Maximum concentration of the analyte in plasma) | up to 360 hours after last drug administration |
| RA (AUC) Accumulation factor based on AUC-data | up to 360 hours after last drug administration |
| RA (Ae) Accumulation factor based on Ae-data | up to 120 hours after last drug administration |
| RA (Cmax) Accumulation factor based on Cmax -data | up to 360 hours after drug administration on day 9 |
| Cav (Average plasma concentration in a steady state interval) | 24 hours after drug administration of day 9 |
| Percent peak-trough fluctuation | up to 360 hours after last drug administration |
| Tmax (Time to maximum observed concentration of the analyte in plasma) | up to 360 hours after last drug administration |
| Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG) | up to 8 days after last blood sample |
Outcome results
None listed