Anti-inflammatory Effects of GTS-21 After LPS

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

December 31, 2009

Study Completion Date

August 31, 2010

Conditions
EndotoxemiaSepsisVagal Activity
Interventions
DRUG

GTS-21, [3-(2,4-dimethoxybenzylidene)-anabaseine dihydrochloride]

Subjects will receive GTS-21 or placebo 3 day before injection of LPS (150 mg tid) and a single oral dose of 150 mg of GTS-21 or placebo the morning of LPS injection (07:00 AM). Subjects will then receive an oral dose of 150 mg GTS-21 or placebo at 08:00 AM and another oral dose of 150 mg GTS-21 or placebo at 1 hour before LPS administration (t=0)

DRUG

Placebo

Subjects will receive placebo 3 day before injection of LPS (150 mg tid) and a single oral dose of 150 mg of placebo the morning of LPS injection (07:00 AM). Subjects will then receive an oral dose of 150 mg placebo at 08:00 AM and another oral dose of 150 mg placebo at 1 hour before LPS administration (t=0).

DRUG

Lipopolysaccharide E. Coli 113:H 10:K negative

Subjects will be randomized to oral pre-treatment with GTS-21 (150 mg tid 3 days before LPS injection and an oral dose of 150 mg GTS-21 on the morning of the day of the experiment (07:00 AM). Subjects will then receive an oral dose of 150 mg GTS-21 or placebo at 08:00 AM and another oral dose of 150 mg GTS-21 or placebo at 1 hour before LPS administration (t=0). One hour after ingestion of the last dosage of the study drug, purified LPS prepared from E coli O:113 (2 ng/kg iv) will be injected intravenously.

Trial Locations (1)

6525 GA

Radboud University Nijmegen Medical Centre, Nijmegen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CoMentis

INDUSTRY

lead

Radboud University Medical Center

OTHER