Clinical trial NCT02209805: Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
Official title: Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered Twice Daily Orally (Total Daily Dose 30, 60, and 120 mg) to Healthy Human Subjects for 14 Days. A Double-blind, Placebo-controlled, Parallel Group Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the safety and pharmacokinetics of BIRB 796 BS tablets administered as multiple daily doses at various dose levels.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age \>= 18 and \<= 45 years
* Broca \>= - 20 % and \<= + 20%
* Able to communicate well with the investigator and to comply with study requirements
* \> 10 elimination half lives present since last use of any investigational drug for that investigational drug
* Laboratory values within a clinically relevant reference range

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, temperature, and EKG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) 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
* History of vasculitis (past history of fever, malaise, myalgias, rash, etc.)
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial, (\< 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 1 months prior to administration or during trial)
* Smoker
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) \< one week prior to administration of study drug
* Blood donation or loss \> 400 mL (\< 1 month prior to administration or during the trial)
* Excessive physical activities (\< 5 days prior to administration or during the trial)
* Following specific laboratory findings: total white blood cell \>= 10 x 109/L, C-Reactive Protein \>= 4.5 mg/L, gamma-glutamyl-transferase \>= 25 U/L, aspartate transaminase \>= 16 U/L, alanine transaminase \>= 20 U/L any erythrocytes or \> 15 mg/dl protein on urine dipstick
* Any EKG value outside of the reference range of clinical relevance including, but not limited to QTcB \> 480 ms, PR interval \> 240 ms, QRS interval \> 110 ms
* History of any familial bleeding disorder
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions

Primary outcomes:
measure: Number of patients with clinically significant changes in vital signs
timeFrame: up to 21 days
measure: Number of patients with clinically significant changes in laboratory parameters
timeFrame: up to 21 days
measure: Number of patients with abnormal findings in electrocardiogram
timeFrame: up to 21 days
measure: Number of patients with adverse events
timeFrame: up to 24 days
Secondary outcomes:
measure: Maximum concentration of the analyte in plasma (Cmax) for several time points
timeFrame: up to 36 hours after dosing
measure: Area under the plasma concentration versus time curve (AUC) for several time points
timeFrame: up to 36 hours after dosing
measure: Time at which maximum plasma concentration occurred over a dosing interval (tmax)
timeFrame: up to 36 hours after dosing
measure: Terminal elimination rate constant (λZ)
timeFrame: up to 36 hours after dosing
measure: Elimination half-life (t1/2)
timeFrame: up to 36 hours after dosing
measure: Mean residence time (MRT)
timeFrame: up to 36 hours after dosing
measure: Apparent oral clearance (CL/F)
timeFrame: up to 36 hours after dosing
measure: Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
timeFrame: up to 36 hours after dosing
Other outcomes:
Locations:
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