Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers
- Registration Number
- NCT02224079
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIIB 722 CL BIIB 722 CL - BIIB 722 CL Placebo - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Plasma concentration time profiles 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 Terminal half-life of the analyte in plasma (t1/2) up to 96 hours after drug administration Maximum measured concentration of the analyte in plasma (Cmax) up to 96 hours after drug administration Amount of drug excreted into urine (Ae) up to 72 hours after drug administration Mean residence time of the analyte in the body (MRT) up to 96 hours after drug administration Total clearance of the analyte in plasma (CL) up to 96 hours after drug administration Apparent volume of distribution at steady state (Vss) up to 96 hours after drug administration