NCT03231124

Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.

A Phase 1, Single Centre Randomised, Double-blind Placebo-controlled Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects. Data obtained from this trial will be used to compare with existing data from the other Phase 1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects will allow the inclusion of Japanese patients into Phase 2b studies.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	LEO 32731	LEO 32731 is being developed by LEO Pharma.
DRUG	Placebo	Placebo contains the same excipients in the same concentration, only lacking LEO 32731

Timeline

• Start date: 2017-07-25
• Primary completion: 2017-08-22
• Completion: 2017-08-22
• First posted: 2017-07-27
• Last updated: 2021-06-29

Locations

1 site across 1 country: United Kingdom