NCT02055716

Sulforadex in Healthy Human Males MAD

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

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

Summary

To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male volunteers over 7 days with qd or bid dosing

Detailed description

This study will be conducted in a randomised, double-blind, placebo-controlled design with multiple ascending doses of Sulforadex® administered qd \[once daily\] or bid \[twice daily\]) to healthy male subjects between 18 to 45 years of age.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Sulforadex
DRUG	alpha-cyclodextrin

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2014-02-05
• Last updated: 2015-02-10

Locations

1 site across 1 country: United Kingdom