Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers

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

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIB 722 CL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB 722 CL<br> | Drug: BIIB 722 CL<br> <br> Drug: Placebo<br>* Hydroxypropyl-beta-cyclodextrin (HPβCD)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Hydroxypropyl-beta-cyclodextrin (HPβCD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | up to 12 days after drug administration | 
| Number of subjects with clinically significant findings in vital signs | blood pressure, pulse rate, respiratory rate, oral body temperature | up to 12 days after drug administration | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration time profiles |  | 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 | 
| 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 | 
| 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 | 
| Amount of drug excreted into urine (Ae) |  | up to 72 hours after drug administration |