Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects

Study Overview
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Brief Summary
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Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL

Official Title
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Tolerability and Pharmacokinetics of Single Oral Administration of 10, 20, 50, 100, 200 and 300 mg BIIB 722 CL (Calculated as Free Base) as Drinking Solution and of 200, 450, 600 and 750 mg BIIB 722 CL as Filmcoated Tablet in Healthy Subjects. An Open Study With Rising Doses, Partly Uncontrolled Intra-individual Comparison, Placebo Randomised Double Blind at Each Dose Level.

Conditions
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Healthy

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


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 Electrocardiogram (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 or during trial Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days Alcohol abuse (> 60g/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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB 722 CL single rising dose<br> | Drug: BIIB 722 CL solution<br> <br> |
| Experimental: BIIB 722 CL cross over<br> | Drug: BIIB 722 CL solution<br> <br> Drug: BIIB 722 CL tablet<br> <br> |
| Placebo Comparator: Placebo solution<br> | Drug: Placebo solution<br> <br> |
| Placebo Comparator: Placebo tablet<br> | Drug: Placebo tablet<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 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 | 
| Total mean residence time of the analyte in the body (MRTtot) |  | up to 96 hours after drug administration | 
| Total clearance of the analyte in plasma (CLtot/f) |  | up to 96 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | up to 96 hours after drug administration | 
| Number of subjects with clinically significant findings in vital functions |  | up to 96 hours after drug administration | 
| Number of subjects with clinically significant findings in laboratory tests |  | up to 96 hours after drug administration | 
| Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery |  | up to 24 hours after drug administration |