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

NCT ID: NCT02209805

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIRB 796 BS, low dose

Group Type: EXPERIMENTAL

BIRB 796 BS, low dose

Intervention Type: DRUG

BIRB 796 BS, high dose

Group Type: EXPERIMENTAL

BIRB 796 BS, high dose

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

BIRB 796 BS, medium dose

Group Type: EXPERIMENTAL

BIRB 796 BS, low dose

Intervention Type: DRUG

BIRB 796 BS, high dose

Intervention Type: DRUG

Interventions

BIRB 796 BS, low dose

Intervention Type: DRUG

BIRB 796 BS, high dose

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1175.14

Identifier Type: -

Identifier Source: org_study_id