Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers

Study Overview
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Brief Summary
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Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL

Official Title
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Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 200 and 300 mg BIIB 722 CL Tablet Tid and 300 and 450 mg BIIB 722 CL Tablet Bid Over 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level.

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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB 722 CL<br> | Drug: BIIB 722 CL<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Dose proportionality | assessed by AUC | up to day 7 | 
| Accumulation factor | (predose concentration/concentration after 8 hours) | up to day 7 | 
| Time to reach steady state |  | up to day 7 | 
| Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery | in vitro fluorescence | up to day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | up to day 12 | 
| 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 |