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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2022-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess Cardiac Conduction of GSK1349572

NCT00996021

Healthy Subjects

COMPLETED PHASE1

Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

NCT02062203

Healthy Volunteers

COMPLETED PHASE1

A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People

NCT05050279

Healthy Volunteers

COMPLETED EARLY_PHASE1

Effect of BIA 5 1058 on Cardiac Repolarization

NCT03489005

Cardiovascular Disease Pulmonary Arterial Hypertension Heart Failure

COMPLETED PHASE1

TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects

NCT04168723

Healthy Volunteers

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers Cardiac Repolarisation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LEO 152020 Dose A

A single oral dose of LEO 152020 Dose A according to the randomization schedule.

Group Type EXPERIMENTAL

LEO 152020

Intervention Type DRUG

Film-coated tablet

Route of administration: Orally

50 mg tablets

LEO 152020 Dose B

A single dose of LEO 152020 Dose B according to the randomization schedule.

Group Type EXPERIMENTAL

LEO 152020

Intervention Type DRUG

Film-coated tablet

Route of administration: Orally

50 mg tablets

Moxifloxacin

A single oral dose of moxifloxacin 400 mg according to the randomization schedule.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Tablet (may be film-coated depending on brand)

Route of administration: Orally

400 mg tablet

Placebo

A single dose of placebo according to the randomization schedule.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Film-coated tablet

Route of administration: Orally

No active ingredient

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LEO 152020

Film-coated tablet

Route of administration: Orally

50 mg tablets

Intervention Type DRUG

Moxifloxacin

Tablet (may be film-coated depending on brand)

Route of administration: Orally

400 mg tablet

Intervention Type DRUG

Placebo

Film-coated tablet

Route of administration: Orally

No active ingredient

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men or women between 18 and 55 years of age, inclusive, at screening.
* Body mass index between 18.0 and 30.0 kg/m2, inclusive.
* In good health at screening and check-in (as applicable) for Treatment Period 1, as assessed by the investigator (or designee) based on medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable).
* Female subjects of childbearing potential must be willing to comply with the contraception requirements.

Exclusion Criteria

* ECG with any clinically relevant abnormality, such as QTcF \>450 ms (males) or \>460 ms (females), QRS duration \>110 ms, or PR interval \>220 ms.
* Subjects at risk for Torsades de pointes based on any of the following:

1. Uncorrected hypokalaemia or hypomagnesaemia at screening or check-in for Treatment Period 1, history of cardiac failure, history of clinically significant/symptomatic bradycardia.
2. (Congenital) long QT syndrome or family history of idiopathic sudden death.
* Known history of ventricular arrhythmias.
* Second- or third-degree atrioventricular block.
* Use or intend to use any medications or products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in for Treatment Period 1, considered to potentially impact subject safety or the objectives of the trial, as determined by the investigator (or designee).
* Use of tobacco- or nicotine-containing products within 3 months prior to check-in for Treatment Period 1, or positive cotinine at screening or check-in for Treatment Period 1.

Other protocol defined criteria may apply.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes