Healthy
Conditions
Brief summary
The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data
Interventions
DRUGBIIX 1 XX - single rising dose
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
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 * Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130% * In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study * As part of the screening (within 14 days before drug administration), 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 3 months |
| Number of subjects with abnormal changes in laboratory parameters | up to 8 days after last drug administration |
| Change in impedance cardiography | up to 30 minutes after drug administration |
| Change in cutaneous microcirculation | up to 30 minutes after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 168 hours after drug administration |
| Ae (Amount of analyte that is eliminated in urine) | up to 48 hours after drug administration |
| Change in airway resistance (Raw) after methacholine challenge | up to 30 minutes after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 168 hours after drug administration |
| CL/F(Apparent clearance of the analyte in plasma following extravascular administration) | up to 168 hours after drug administration |
| MRT (Mean residence time of the analyte in the body) | up to 168 hours after drug administration |
| Change in specific conductance (sGaw) after methacholine challenge | up to 30 minutes after drug administration |
| AUC (Area under the concentration-time curve of the analyte in plasma) | up to 168 hours after drug administration |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 168 hours after drug administration |
Outcome results
None listed