EtOH Interaction Study

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 29, 2008

Primary Completion Date

December 3, 2008

Study Completion Date

December 3, 2008

Conditions
Substance Dependence
Interventions
DRUG

GSK598809

Two 175 mg doses of GSK598809 will be given.

OTHER

Ethanol

A constant ethanol level of 0.6 g·L-1 for five hours will be given to the subjects intravenously. This level shows significant CNS effects, without causing too many inadvertent events. Furthermore this level is considered safe as it is just above the legal driving limit in the Netherlands (i.e. 0.5 g·L-1) and these levels are routinely achieved during social drinking. Moreover, this level leaves enough room for CNS-impairment without compromising safety, in case of a (supra-) addictive drug-alcohol interaction.

Trial Locations (1)

2333 CL

GSK Investigational Site, Leiden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00887367 - EtOH Interaction Study | Biotech Hunter | Biotech Hunter