Effect of Single Oral Dose BIRB 796 BS on Endotoxin-induced Inflammatory Responses in Healthy Human Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 796 BS, low dose; Drug: Placebo; Drug: BIBR 796 BS, high dose; Drug: Lipopolysaccharide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02211170

1175.4

Details and patient eligibility

About

Study to determine the effect of a single dose BIRB 796 BS on systemic inflammatory responses induced by endotoxin in healthy humans

Enrollment: 24 patients

Sex: Male

Ages: 18 to 35 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 ≤ 35 years
• Broca ≥- 20 % and ≤ + 20%
• Able to communicate well with the investigator and to comply with study requirements

Exclusion criteria

• Any finding of the medical examination (including blood pressure, pulse rate 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 within 14 days of enrolment
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• 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 (< 3 months prior to administration or during trial)
• Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation or loss > 400 ml (< 2 month prior to administration or during the trial)
• Excessive physical activities (< 24 hours prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance
• History of any familial bleeding disorder
• Weight > 150 kg
• Prior confirmed or suspected receipt of a monoclonal antibody

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

BIBR 796 BS, low dose

Experimental group

Treatment:

Drug: BIBR 796 BS, low dose

Drug: Lipopolysaccharide

BIBR 796 BS, high dose

Experimental group

Treatment:

Drug: BIBR 796 BS, high dose

Drug: Lipopolysaccharide

Placebo

Placebo Comparator group

Treatment:

Drug: Lipopolysaccharide

Drug: Placebo