Clinical trial NCT02227030: Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL


Eligibility criteria: 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

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
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: Total mean residence time of the analyte in the body (MRTtot)
timeFrame: up to 96 hours after drug administration
measure: Total clearance of the analyte in plasma (CLtot/f)
timeFrame: up to 96 hours after drug administration
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to 96 hours after drug administration
measure: Number of subjects with clinically significant findings in vital functions
timeFrame: up to 96 hours after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 96 hours after drug administration
measure: Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
timeFrame: up to 24 hours after drug administration
Other outcomes:
Locations:
Study officials:
References: