A PET scan study of AVP-923 and AVP-786, version A
Research type
Research Study
Full title
A Phase 1 Study Evaluating the Relationship Between Plasma Concentrations and Serotonin Transporter (SERT) Occupancy of AVP-923 or AVP-786 Using Positron Emission Tomography in Healthy Volunteers (16-031).
IRAS ID
221716
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
Avanir Pharmaceuticals Inc
Eudract number
2017-000281-29
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
AVP-923 and AVP-786 (the study medicines) are 2 experimental medicines for treating conditions that affect mood, behaviour and movement. The active ingredient in AVP-923 is called ‘DM’ (dextromethorphan hydrobromide); AVP-786 contains the active ingredient ‘d6-DM’ (deudextromethorphan hydrobromide). We’re not sure exactly how the study medicines work – they might change levels of certain chemicals in the brain, including a substance called serotonin.
The body breaks down DM and d6-DM quickly, which stops them being effective. AVP-923 and AVP-786 also contain a medicine called quinidine. Quinidine slows the breakdown of DM and d6-DM, which leads to higher blood levels.
We’re doing this study in up to 12 healthy men, aged 20–50, to compare how much of the study medicines get into the brain and attach (‘bind’) to a substance known as the serotonin transporter. That’ll help us investigate how the study medicines affect serotonin. We’ll do PET (positron emission tomography) scans, which make images of the brain. We’ll also assess blood levels of each study medicine and whether they have any important side effects.
Participants will take up to 12 weeks to finish the study. They’ll have 2 screening visits, 2 study sessions and 1 follow-up visit. They’ll stay on the ward for 1 night in the first study session and 6 nights in the second. Overall, participants will have 3 PET scans and 1 MRI (magnetic resonance imaging) scan. In the second study session, participants will take quinidine, twice-daily, for 4 days, followed by a single dose of either study medicine.
For each PET scan, participants will receive radioactive tracer; each participant will be exposed to radiation similar to 3.5 years’ background radiation.
A pharmaceutical company (Avanir Pharmaceuticals, Inc.) is funding the study.The study will take place at 1 research centre and 1 imaging centre in London.
REC name
HSC REC B
REC reference
17/NI/0017
Date of REC Opinion
9 Mar 2017
REC opinion
Further Information Favourable Opinion