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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIRB 796 BS, high dose; Drug: Placebo; Drug: BIRB 796 BS, low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209805

1175.14

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 4 patient groups, including a placebo group

BIRB 796 BS, low dose

Experimental group

Treatment:

Drug: BIRB 796 BS, low dose

BIRB 796 BS, high dose

Experimental group

Treatment:

Drug: BIRB 796 BS, high dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BIRB 796 BS, medium dose

Experimental group

Treatment:

Drug: BIRB 796 BS, high dose

Drug: BIRB 796 BS, low dose