drugset / Trial / NCT05508776

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

NCT05508776 ↗

Phase 1 Completed 28 enrolled JW Pharmaceutical LEO Pharma · collab
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2022-09-16
Primary completion
2022-12-28
Completion
2022-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject LEO 152020 Small molecule 50 mg Oral
Comparator Moxifloxacin Small molecule 400 mg Oral

Indications

No indication recorded.