ASN120290 PET study in healthy volunteers, v1
Research type
Research Study
Full title
A phase 1, open-label, positron emission tomography study in healthy subjects to determine the relationship between plasma concentration and brain target occupancy of ASN120290 in healthy volunteers following a single oral dose. (18-006)
IRAS ID
250862
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Asceneuron S.A.
Eudract number
2018-002665-19
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
The study medicine (ASN120290) is an experimental new medicine for treating progressive supranuclear palsy (PSP), a rare but fatal brain disease causing a wide range of difficulties with balance (including frequent falls), movement, vision, speech and swallowing. Those difficulties also include symptoms such as change in personality, irritability and apathy. PSP is caused by the toxic build-up of a substance called tau in the brain. We hope ASN120290 will work by blocking the activity of a protein called O GlcNAcase (OGA) which is involved in the building-up of pathological tau in the brain. There are no effective treatments available for PSP. \n\nParticipants will have up to 2 screening visits, during which they’ll have an MRI (magnetic resonance imaging) scan. Eligible participants (up to 10 healthy men and women, aged 25–75 years) will take 2 single doses of up to 1000 mg study medicine, by mouth, and will have 3 PET (positron emission tomography) scans to measure how much of ASN120290 gets into the brain and binds to OGA. We’ll also measure blood levels of ASN120290 and whether it has any important side effects.\n\nBefore each PET scan, we’ll give participants an injection of a fluorine-18-labelled radioactive tracer, which binds to OGA and whose presence in the brain will be followed by PET scan. Participants will be exposed to radiation levels similar to 3 years’ background radiation.\n\nEligible participants will take up to about 7 weeks to finish the study. They’ll have 3 study sessions and 1 follow-up visit. They’ll stay on the ward for 1 night in session 1 and for 3 or 4 nights in sessions 2 & 3.\n\nA pharmaceutical company (Asceneuron S.A.) is funding the study.\n\nThe study will take place at 1 research centre and 1 imaging centre in London.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0286
Date of REC Opinion
30 Oct 2018
REC opinion
Further Information Favourable Opinion