Clinical trial NCT02268604: Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess safety, pharmacodynamics and pharmacokinetics 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 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

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma (AUC)
timeFrame: up to day 7
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to day 7
measure: Time to maximum measured concentration of the analyte in plasma (tmax)
timeFrame: up to day 7
measure: Total mean residence time of the analyte in the body (MRTtot)
timeFrame: up to day 7
measure: Total clearance of the analyte in plasma (CLtot/f)
timeFrame: up to day 7
measure: Terminal half-life of the analyte in plasma (t1/2)
timeFrame: up to day 7
measure: Amount of the analyte excreted in urine (Ae)
timeFrame: up to day 7
measure: Dose proportionality
timeFrame: up to day 7
measure: Accumulation factor
timeFrame: up to day 7
measure: Time to reach steady state
timeFrame: up to day 7
measure: Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
timeFrame: up to day 7
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to day 12
measure: Number of subjects with clinically significant findings in vital functions
timeFrame: up to day 12
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to day 12
Other outcomes:
Locations:
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