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

NCT05508776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-04-22

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Expert · LEO Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2022-12-28
Completion
2022-12-28
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508776 on ClinicalTrials.gov