Safety and Pharmacokinetics of BIRB 796 BS Tablets Administered to Healthy Human Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIRB 796 BS, low dose; Drug: BIRB 796 BS, high dose; Drug: Placebo

• Registration Number: NCT02209805
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2001-03
• Status Verified: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Study First Posted: 2014-08-06
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIRB 796 BS, low dose	BIRB 796 BS, low dose	-
BIRB 796 BS, high dose	BIRB 796 BS, high dose	-
BIRB 796 BS, medium dose	BIRB 796 BS, low dose	-
BIRB 796 BS, medium dose	BIRB 796 BS, high dose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of patients with abnormal findings in electrocardiogram	up to 21 days
Number of patients with adverse events	up to 24 days
Number of patients with clinically significant changes in vital signs	up to 21 days
Number of patients with clinically significant changes in laboratory parameters	up to 21 days

Secondary Outcome Measures

Name	Time	Method
Maximum concentration of the analyte in plasma (Cmax) for several time points	up to 36 hours after dosing
Area under the plasma concentration versus time curve (AUC) for several time points	up to 36 hours after dosing
Time at which maximum plasma concentration occurred over a dosing interval (tmax)	up to 36 hours after dosing
Terminal elimination rate constant (λZ)	up to 36 hours after dosing
Elimination half-life (t1/2)	up to 36 hours after dosing
Mean residence time (MRT)	up to 36 hours after dosing
Apparent oral clearance (CL/F)	up to 36 hours after dosing
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)	up to 36 hours after dosing