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Effect of BIBT 986 Followed by BIBT 986 Given as IV Infusion on Tissue Factor Triggered Coagulation in Healthy Male Volunteers

NCT02259881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-10-09

No results posted yet for this study

Summary

To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters of coagulation, platelet activation and inflammation in a model of tissue factor triggered activation of the coagulation system; to examine the safety of BIBT 986 in this setting

Conditions

  • Healthy

Interventions

DRUG

Low dose of BIBT 986 CL, per i.v. infusion

DRUG

Medium dose of BIBT 986 CL, per i.v. infusion

DRUG

High dose of BIBT 986 CL, per i.v. infusion

DRUG

Placebo

DRUG

Lipopolysaccharide (LPS), single i.v. bolus

Endotoxin derived from E. coli bacteria, used for activation of coagulation

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2003-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259881 on ClinicalTrials.gov