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 intranasal 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 * Body Mass Index (BMI) is to 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 local legislation each 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 rhinomanometry (in order to familiarize the subject with this method; screening rhinomanometric values were not to be reported). Moreover laboratory parameters (including drug screening, HBs- antigen (HBs-Ag), anti Hepatitis B core (HBc) - antibodies, anti Hepatitis C Virus (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 |
|---|---|
| Number of patients with adverse events | up to 24 days |
| Number of patients with abnormal changes in laboratory parameters | up to 24 days |
| Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) | up to 24 days |
| Number of patients with clinically significant changes in 12-lead Electrocardiogram (ECG) | up to 24 days |
| Assessment of tolerability on a 4-point scale | 8 days after drug administration |
| Macroscopic changes in nasal mucosa assessed by rhinoscopy | up to 3 hours after drug administration |
| Changes in nasal flow assessed by rhinomanometry | up to 3 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| MRTtot (Total mean residence time of the analyte) | 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 |
| Cmax (Maximum measured concentration 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 |
| CLR (Renal clearance of the analyte in plasma) | 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 |
| 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 |
| t½ (Terminal half-life of the analyte in plasma) | up to 48 hours after drug administration |
| λz (Terminal rate constant 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