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

NCT00783068 - Anti-inflammatory Effects of GTS-21 After LPS | Biotech Hunter | Biotech Hunter