Safety, Tolerance, PK & PD of Sulforadex in healthy males.

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerance, pharmacokinetics and pharmacodynamics of Sulforadex® in healthy male subjects

• IRAS ID

  117098

• Contact name

  Jorg Taubel

• Sponsor organisation

  Evgen Ltd

• Eudract number

  2012-003732-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  We are conducting a first time into human clinical trial with a new medicine known as Sulforadex© at Richmond Pharmacology Ltd (RPL) clinical research unit. Sulforadex© contains a synthetic sulforaphane, which is a chemical found naturally in broccoli and is being developed by Evgen (the sponsor company) to prevent the progression of early-stage prostate cancer. In this study Sulforadex© will only be tested in male volunteers. Unlike many other cancers, prostate cancer usually develops slowly and can be cured if treated in the early stages. A large number of research studies have shown that cruciform (brissica) vegetables (i.e. vegetables such as broccoli whose flowers resemble a Cross) contain specific compoun's which are capable of suppressing the initial phases of carcinoGenesis; that is the transformation of normal cells into cancerous cells. Sulforaphane has been shown to reduce the risk of prostate cancer. Since it is not possible for patients to eat sufficient amounts of broccoli to gain a therapeutic effect, particularly as cooking reduces the effect; Evgen have synthesised a concentrated form of synthetic sulforaphane which is contained in the medicine Sulforadex©. The aim of this study is to assess the safety of Sulforadex© and how well it is tolerated when given to humans. We will also assess the levels of Sulforadex© in the blood (pharmacokinetics) as well as the activity levels of histone deacetylase (HDAC), which is a naturally occurring enzyme in the blood which may be affected by Sulforadex© (pharmacodynamics); following a single oral dose to 29 healthy male volunteers during 1 treatment period. Standard safety assessments including ECGs, vital signs, blood and urine safety tests and monitoring of adverse events (side-effects) will also be done. This will help us to determine suitable oral doses that can be given safely to patients to potentially treat prostate cancer.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0553

• Date of REC Opinion

  19 Nov 2012

• REC opinion

  Favourable Opinion