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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BIRB 796 BS, low dose; Drug: BIRB 796 BS, high dose

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BIRB 796 BS, low dose	Drug: BIRB 796 BS, low dose
Experimental: BIRB 796 BS, high dose	Drug: BIRB 796 BS, high dose
Experimental: BIRB 796 BS, medium dose	Drug: BIRB 796 BS, low dose; Drug: BIRB 796 BS, high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Number of patients with abnormal findings in electrocardiogram	up to 21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): March 1, 2001

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1175.14