Clinical trial NCT02224079: Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers
Official title: Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated as 'Free Base') and HPβCD Given as Intravenous Infusion Over 30 Minutes to Young Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.) doses of BIIB 722 CL


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 12 days after drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 12 days after drug administration
measure: Number of subjects with clinically significant findings in ECG
timeFrame: up to 12 days after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 12 days after drug administration
Secondary outcomes:
measure: Plasma concentration time profiles
timeFrame: up to 96 hours after drug administration
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 96 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma (tmax)
timeFrame: up to 96 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from time zero to a specified point in time (AUC0-t)
timeFrame: up to 96 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
timeFrame: up to 96 hours after drug administration
measure: Mean residence time of the analyte in the body (MRT)
timeFrame: up to 96 hours after drug administration
measure: Total clearance of the analyte in plasma (CL)
timeFrame: up to 96 hours after drug administration
measure: Apparent volume of distribution at steady state (Vss)
timeFrame: up to 96 hours after drug administration
measure: Amount of drug excreted into urine (Ae)
timeFrame: up to 72 hours after drug administration
Other outcomes:
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