NCT05508776

A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People

Interventional, Randomised, Partially Double-blind, Crossover, Positive-controlled, Single-dose Trial Investigating the Effect of LEO 152020 on Cardiac Repolarisation in Healthy Men and Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The trial medicine (LEO 152020) is being developed to treat people with eczema. The aims of this trial are to find out about: * How the trial medicine affects participant's heart rhythm. * How much of the trial medicine is absorbed into the bloodstream, and how quickly the body gets rid of it. * The safety of the trial medicine and any side effects that might be related to it. The trial will last up to 45 days, and there will be up to 6 visits. Four treatment periods are planned for this trial. In each treatment period, participant will receive a single dose of the trial medicine at dose A, trial medicine at dose B, dummy tablet, or an approved medication named moxifloxacin (used for the treatment of bacterial infections). The order of these 4 treatment periods is chosen at random. Participant will receive all 4 treatments; it is only the order of the treatments that is random. There will be 6 trial visits and they will include 1 screening visit, 4 treatment period visits and 1 final, follow-up visit at the clinic. The 4 treatment period visits will last for 3 days, from Day -1 (check-in to the clinic) to Day 2 (check-out of the clinic). There will be a period of at least 3 days between the 4 dosing occasions.

Conditions

• Healthy Volunteers
• Cardiac Repolarisation

Interventions

Type	Name	Description
DRUG	LEO 152020	Film-coated tablet Route of administration: Orally 50 mg tablets
DRUG	Moxifloxacin	Tablet (may be film-coated depending on brand) Route of administration: Orally 400 mg tablet
DRUG	Placebo	Film-coated tablet Route of administration: Orally No active ingredient

Timeline

• Start date: 2022-09-16
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2022-08-19
• Last updated: 2024-04-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study