Healthy
Conditions
Brief summary
Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL
Interventions
DRUGBIIB 722 CL
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 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 of during trial * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days * Alcohol abuse (\> 60 g/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 | Description |
|---|---|---|
| Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery | up to day 7 | in vitro fluorescence |
| Dose proportionality | up to day 7 | assessed by AUC |
| Accumulation factor | up to day 7 | (predose concentration/concentration after 8 hours) |
| Time to reach steady state | up to day 7 | — |
| Area under the concentration-time curve of the analyte in plasma (AUC) | up to day 7 | — |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to day 7 | — |
| Time to maximum measured concentration of the analyte in plasma (tmax) | up to day 7 | — |
| Total mean residence time of the analyte in the body (MRTtot) | up to day 7 | — |
| Total clearance of the analyte in plasma (CLtot/f) | up to day 7 | — |
| Terminal half-life of the analyte in plasma (t1/2) | up to day 7 | — |
| Amount of the analyte excreted in urine (Ae) | up to day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with clinically significant findings in vital functions | up to day 12 |
| Number of subjects with clinically significant findings in laboratory tests | up to day 12 |
| Number of subjects with adverse events | up to day 12 |
Outcome results
None listed