Bioavailability of Arbaclofen Placarbil (QCL117852)
Research type
Research Study
Full title
A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers
IRAS ID
214300
Contact name
Frank Grey
Contact email
Sponsor organisation
Indivior
Eudract number
2016-003792-22
ISRCTN Number
NCT03058237
Duration of Study in the UK
0 years, 5 months, 18 days
Research summary
The Sponsor is developing the study drug, Arbaclofen placarbil (AP), for the potential treatment of alcohol use disorder (AUD).
AUD is linked with imbalances of chemicals in the brain. Baclofen, a drug that activates one of the pathways associated with these chemical in the brain, was originally approved in the United States for use in spasticity (a muscle control disorder characterised by tight or stiff muscles). Several reports have suggested that baclofen could reduce craving for alcohol and alcohol intake, increase the time to first drink and increase the number of days without alcohol. Baclofen has been studied in alcohol-dependent patients, however these studies produced differing results.
AP is a prodrug of R-baclofen. A prodrug is a compound that is broken down in the body to form the active drug. Indivior are developing new formulations of AP that may be taken up by the body better than baclofen.
This study will consist of 3 parts that will look at how different formulations of Arbaclofen placarbil are taken up by the body.
REC name
HSC REC A
REC reference
16/NI/0250
Date of REC Opinion
25 Nov 2016
REC opinion
Favourable Opinion