NCT01310049

LEO 32731 - A Study in Healthy Male Subjects

LEO 32731 - A Phase I, Single-Blind, Placebo Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this first-in-man trial is to determine the safety and tolerability of ascending single and multiple doses of LEO 32731 in healthy male subjects. The trial will be performed in three parts. In Part 1, single doses of LEO 32731 will be administered to healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy male subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	LEO 32731	* Part 1 and 2: Oral single dose of oral solution or capsule * Part 3: Twice daily dose of oral solution or capsule for 7 days

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2011-03-07
• Last updated: 2013-11-05

Locations

1 site across 1 country: United Kingdom