NCT02211170

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
14.4 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

August 5, 2014

Last Update Submit

August 5, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Reduction of tumour necrosis factor alpha (TNFα) concentration

    up to 2 days

Secondary Outcomes (20)

  • Reduction of pro-inflammatory cytokines (IL-6, IL-8, G-CSF)

    up to 2 days

  • Reduction of anti-inflammatory cytokine and cytokine inhibitors (IL-10, IL-12p40, soluble TNF receptor (sTNFr) type 1, IL-1ra)

    up to 2 days

  • Reduction of Acute Phase Proteins (C-reactive protein, Haptoglobin)

    up to 2 days

  • Reduction of Endothelial Activation Markers (von Willebrand Factor, soluble E-selectin)

    up to 2 days

  • Reduction of Granulocyte Responses (white blood cell (WBC) count with differential, elastase, elastase-á1-antitrypsin complexes)

    up to 2 days

  • +15 more secondary outcomes

Study Arms (3)

BIBR 796 BS, low dose

EXPERIMENTAL
Drug: BIBR 796 BS, low doseDrug: Lipopolysaccharide

BIBR 796 BS, high dose

EXPERIMENTAL
Drug: BIBR 796 BS, high doseDrug: Lipopolysaccharide

Placebo

PLACEBO COMPARATOR
Drug: PlaceboDrug: Lipopolysaccharide

Interventions

BIBR 796 BS, low doseDRUG
BIBR 796 BS, low dose
BIBR 796 BS, high doseDRUG
BIBR 796 BS, high dose
PlaceboDRUG
Placebo
LipopolysaccharideDRUG

Lipopolysaccharide (LPS) for endotoxin challenge

BIBR 796 BS, high doseBIBR 796 BS, low dosePlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lipopolysaccharides

Intervention Hierarchy (Ancestors)

GlycoconjugatesCarbohydratesPolysaccharides, BacterialPolysaccharidesLipidsAntigens, BacterialAntigensBiological FactorsEndotoxinsBacterial ToxinsToxins, Biological

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 7, 2014

Study Start

February 1, 2000

Primary Completion

April 1, 2000

Last Updated

August 7, 2014

Record last verified: 2014-08