CORT125281 – first dose in humans; version 1
Research type
Research Study
Full title
A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-ascending Oral Doses of CORT125281 in Healthy Subjects (17-001). \n
IRAS ID
224892
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Corcept Therapeutics
Eudract number
2017-000837-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine, CORT125281, is an experimental treatment as a targeted therapy for prostate cancer. The prostate is part of the male reproductive system, and prostate cancer is the most common male cancer in Europe. Male hormones (androgens) cause prostate tumours to grow. Treatments that block androgen production are effective at first but, the cancer often comes back and is resistant to those treatments. We hope that the study medicine will work in patients whose prostate cancer has come back, by working with current androgen-blocking treatments to increase their clinical benefit. \n\nWe’ll test single and repeated doses of CORT125281 in up to 50 healthy volunteers, aged 18–65 years, to find out its side effects and blood levels. CORT125281 has never been given to humans before, so, in each part, we’ll start with a small dose, and increase the dose as the study progresses. \n\nThe study has two parts:\n\nPart 1: all 18 participants will receive single oral doses of CORT125281 or placebo. Each participant will have up to 3 study sessions, and will take a single dose of CORT125281 or placebo in each session. Once each session they’ll take a single dose of test medicine, prednisone (shows concentration in humans). Part 1 will take about 10 weeks to complete. Participants will stay on the ward for 4 nights per session and make 2 outpatient visits. \n\nPart 2: up to 32 participants will receive daily doses of CORT125281 or placebo for 14 days. They’ll also take 2 doses of a test medicine, pioglitazone (activity marker of an enzyme). Part 2 will take about 8.5 weeks to complete. Participants will stay on the ward for 19 nights and make 2 outpatient visits. \n \nA pharmaceutical company (Corcept Therapeutics) is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
HSC REC A
REC reference
17/NI/0048
Date of REC Opinion
2 May 2017
REC opinion
Further Information Favourable Opinion