Safety PK and PD of multiple doses of Sulforadex in healthy males
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerance, pharmacokinetics and pharmacodynamics of Sulforadex® in healthy male subjects following daily dosing for 7 days
IRAS ID
145252
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Evgen Ltd
Eudract number
2013-004454-19
Research summary
We are conducting a clinical trial at Richmond Pharmacology Ltd with a new drug called Sulforadex® which is being developed by Evgen Ltd (the sponsor company) for preventing the progression of early-stage prostate cancer. Sulforadex® contains a naturally occurring compound known as ’sulforaphane’ which is found in brassica vegetables such as broccoli and has been shown to slow down the progression of prostate cancer and other cancers. Broccoli does not contain enough of this compound, that is why it has been formulated as Sulforadex® tablet. Sulforadex® is intended for chronic use so patients will take it for several years. Therefore we need to determine the right dose and the right frequency of dosing. i.e. whether to give Sulforadex® once or several times per day. It is anticipated that Sulforadex® will be more effective and will have fewer and milder side-effects than other medicines currently used for treatment of prostate cancer.
The aim of this clinical trial is to assess the safety and tolerability of Sulforadex® and to measure the levels in the blood (pharmacokinetics) following multiple oral doses given once daily or twice daily to 18 healthy male volunteers, in 3 increasing doses. We will also measure the activity levels of a naturally occurring enzyme in the blood, known as histone deacetylase (HDAC), that may be affected by Sulforadex® (i.e. pharmacodynamics) which will allow us to estimate the potential treatment effects before commencing studies in patients. Standard safety assessments and observations of side effects will also be carried out and an exploratory blood sample will be taken for genetic (DNA) analysis. The study will take approximately 45 days to complete, including the screening, conduct of the study during one residential period of 10 days (9 nights) and the follow-up. The results from this study will help us to design future studies.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/1688
Date of REC Opinion
8 Jan 2014
REC opinion
Further Information Favourable Opinion