Healthy
Conditions
Brief summary
The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing doses in healthy male and female volunteers
Interventions
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants should be healthy males and females * Age range from 21 to 50 years * (Broca-Index): within +-20% of their normal weight * In accordance with Good Clinical Practice (GCP) and local legislation all volunteers are supposed to give their 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) and a lung function test (Raw, SGaw). Moreover laboratory parameters (including drug screening, HBs-antigen (HBs-Ag), anti HBc-antibodies, anti HCV- antibodies and Human immunodeficiency virus (HIV) test as well as pregnancy test for female subjects are to be determined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of tolerability on a 4-point scale | 8 days after drug administration |
| Number of patients with adverse events | up to 24 days |
| Change in lung function measurement specific conductance (SGaw) | up to 5 hours after drug administration |
| Change in lung function measurement airway resistance (Raw) | up to 5 hours after drug administration |
| Number of patients with clinically relevant changes in Blood Pressure | up to 24 days |
| Number of patients with clinically relevant changes in Pulse Rate | up to 24 days |
| Number of patients with clinically relevant changes in Electrocardiogram | up to 24 days |
| Number of patients with clinically relevant changes in standard laboratory evaluation | up to 24 days |
Secondary
| Measure | Time frame |
|---|---|
| MRTtot (Total mean residence time of the analyte molecules in the body) | up to 48 hours after drug administration |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 48 hours after drug administration |
| CLR (Renal clearance of the analyte in plasma) | up to 48 hours after drug administration |
| Ae (Amount of parent drug excreted into urine) | up to 24 hours after drug administration |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 48 hours after drug administration |
| AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 48 hours after drug administration |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 48 hours after drug administration |
| AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) | up to 48 hours after drug administration |
| λz (Terminal rate constant in plasma) | up to 48 hours after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 48 hours after drug administration |
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) | up to 48 hours after drug administration |
Outcome results
None listed