Healthy
Conditions
Brief summary
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
Interventions
DRUGPlacebo
Hydroxypropyl-beta-cyclodextrin (HPβCD)
DRUGBIIB 722 CL
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males * 21 to 50 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 or hormonal disorders * Diseases of the central nervous system or psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells or blackouts * 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 at least one month or less than ten half-lives of the respective drug before enrolment in the study * Use of any drugs, which might influence the results of the trial within two weeks prior to administration or during the trial * Participation in another trial with an investigational drug (\<= two months prior to administration or during trial) * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on study days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (\>= 100 mL within four weeks prior to administration or during the trial) * Excessive physical activities (within the last week before the study) * Any laboratory value outside the reference range of clinical relevance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | up to 12 days after drug administration | — |
| Number of subjects with clinically significant findings in vital signs | up to 12 days after drug administration | blood pressure, pulse rate, respiratory rate, oral body temperature |
| Number of subjects with clinically significant findings in ECG | up to 12 days after drug administration | — |
| Number of subjects with clinically significant findings in laboratory tests | up to 12 days after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life of the analyte in plasma (t1/2) | up to 96 hours after drug administration |
| Mean residence time of the analyte in the body (MRT) | up to 96 hours after drug administration |
| Plasma concentration time profiles | up to 96 hours after drug administration |
| Apparent volume of distribution at steady state (Vss) | up to 96 hours after drug administration |
| Amount of drug excreted into urine (Ae) | up to 72 hours after drug administration |
| Total clearance of the analyte in plasma (CL) | 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 |
| Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t) | up to 96 hours after drug administration |
Outcome results
None listed