Healthy
Conditions
Brief summary
Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
Interventions
DRUGBIIB 722 CL solution
DRUGBIIB 722 CL tablet
DRUGPlacebo solution
DRUGPlacebo tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males * 18 to 55 years of age * Broca index \>= -20% and \<= +20% * Written informed consent according to Good Clinical Practice (GCP) and local legislation
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance * History or current gastrointestinal hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders * History of orthostatic hypotension, fainting spells or blackouts * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration * Use of any drugs, which might influence the results of the trial within 10 days prior to administration or during the trial * Participation in another trial with an investigational drug within 2 months prior to administration or during trial * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days * Alcohol abuse (\> 60g/day) * Drug abuse * Blood donation within 1 month prior to administration or during the trial * Excessive physical activities within 5 days prior to administration or during the trial * Any laboratory value outside the clinically accepted reference range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total clearance of the analyte in plasma (CLtot/f) | up to 96 hours after drug administration |
| Area under the concentration-time curve of the analyte in plasma (AUC) | up to 96 hours after drug administration |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 96 hours after drug administration |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | up to 96 hours after drug administration |
| Total mean residence time of the analyte in the body (MRTtot) | up to 96 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with clinically significant findings in vital functions | up to 96 hours after drug administration |
| Number of subjects with clinically significant findings in laboratory tests | up to 96 hours after drug administration |
| Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery | up to 24 hours after drug administration |
| Number of subjects with adverse events | up to 96 hours after drug administration |
Outcome results
None listed