A PET scan study to assess brain uptake of SK-1405, v1
Research type
Research Study
Full title
A Phase I Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects. HMR code 15-025
IRAS ID
192737
Contact name
Adeep Puri
Contact email
Sponsor organisation
Sanwa Kagaku Kenkyusho Co., Ltd
Eudract number
2015-004409-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
SK-1405 is an experimental new medicine for treating pruritus. Pruritus is severe itchiness in a particular area, or over the whole body, that can be caused by other illnesses, such as kidney disease. Some people being treated for kidney disease have a kind of pruritus that is itchy all the time, and can be frustrating to live with. That type of pruritus is thought to be caused by substances in the blood that bind to specific sites (called receptors) in the brain, which make people itchy. We hope that SK-1405 will work by blocking those receptors.
There are existing medicines for pruritus, but most cause unpleasant side effects, or don’t work in people with kidney disease. We hope that SK-1405 will have fewer side effects than current treatments.
Up to 10 healthy Caucasian men, aged 20–50 years, will have PET (positron emission tomography) scans to measure how much SK 1405 binds to specific receptors in the brain.
Participants will have up to 2 screening visits, during which they’ll have an MRI (magnetic resonance imaging) scan. Eligible participants will take a single dose of up to 120 mg SK-1405, by mouth, and have 3 PET scans. During each PET scan, participants will receive a small dose of carbon-11-labelled radioactive tracer by injection. The tracer binds the same receptors in the brain as SK-1405, and the PET scan shows where the tracer is. Each participant will be exposed to radiation similar to 2.5 years’ background radiation.Participants will take up to 8 weeks to finish the study, have up to 5 outpatient visits and stay on the ward for up to 5 nights.
A pharmaceutical company, Sanwa Kagaku Kenkyusho Co., Ltd. is paying for the study.
The study will take place at a research unit and an imaging centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1867
Date of REC Opinion
17 Dec 2015
REC opinion
Further Information Favourable Opinion