Healthy
Conditions
Brief summary
The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
Interventions
DRUGBIIX 1 XX - D1
DRUGBIIX 1 XX - D2
DRUGBIIX 1 XX - D3
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
* Healthy male volunteers who have Broca-Indices within +-20% * Participants in the age range between 21 to 50 years * 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. Subsequently each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/
Exclusion criteria
and concomitant therapy) as well as a 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 day 28 |
| Number of subjects with abnormal changes in laboratory parameters | up to day 21 |
| Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) | up to day 21 |
| Number of subjects with clinically significant changes in ECG (Electrocardiogram) | up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| MRT (mean time of residence of drug molecules in the body ) | up to 336 hours after last drug administration |
| AUC (Total Area under the plasma drug concentration time curve) | up to 336 hours after last drug administration |
| CL (Total clearance of the analyte in plasma following extravascular administration) | up to 336 hours after last drug administration |
| Cmax (maximum observed concentration of the analyte in plasma) | up to 336 hours after last drug administration |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 336 hours after last drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 336 hours after last drug administration |
Outcome results
None listed