NCT01948362

Sulforadex in Healthy Volunteers SAD

A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Sulforadex® in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Evgen Pharma · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy male volunteers.

Detailed description

This study will be conducted in a randomised, double-blind, placebo-controlled design with single ascending doses of Sulforadex® administered to healthy male subjects between 18 to 45 years of age. Each healthy subject will receive verbal and written information followed by signing of the Informed Consent Form (ICF). Subjects will be screened within 21 days prior to admission. At this visit a medical examination will be performed to assess eligibility of the healthy subject. Screening will be conducted over 1 day or may be divided into more than 1 day. The first cohort of the study will commence with one sentinel group. The subsequent groups may be dosed together without sentinel dosing. The study is expected to have 5 cohorts with a total of 29 healthy male subjects:

Conditions

• Stage, Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sulforadex	Active compound
DRUG	Alpha cyclodextrin	Placebo control

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-09-23
• Last updated: 2013-09-23

Locations

1 site across 1 country: United Kingdom