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Completed

NCT Number: NCT05508776

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

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.

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Key information

Conditions

Healthy Volunteers Cardiac Repolarisation

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LEO Investigational Site

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Uncorrected hypokalaemia or hypomagnesaemia at screening or check-in for Treatment Period 1, history of cardiac failure, history of clinically significant/symptomatic bradycardia.
  • (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.

Treatment and study plan

LEO 152020

Drug

Film-coated tablet

Route of administration: Orally

50 mg tablets

moxifloxacin

Drug

Tablet (may be film-coated depending on brand)

Route of administration: Orally

400 mg tablet

Placebo

Drug

Film-coated tablet

Route of administration: Orally

No active ingredient

Primary outcomes

  1. Placebo-corrected change from baseline of LEO 152020 using QT interval corrected using Fridericia's formula (ΔΔQTcF)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

Secondary outcomes

  1. Change from baseline of Heart Rate (ΔHR)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  2. Change from baseline of QT interval corrected using Fridericia's formula (ΔQTcF)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  3. Change from baseline of Pulse Rate (ΔPR)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  4. Change from baseline of QRS interval (ΔQRS)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  5. Placebo-corrected, change from baseline of Heart Rate (ΔΔHR)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  6. Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  7. Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  8. Categorical outliers for QTcF, HR, PR interval, and QRS duration

    Time frame: Predose up to 24 hours postdose for each applicable treatment

    A continuous 12-lead electrocardiogram recording (Holter) will be performed for at least 25 hours, starting 1 hour predose on Day 1 and encompassing the entire period from prior to the first (predose) extraction time point until after the last (24 hours postdose) extraction time point.

  9. Maximum observed plasma concentration of LEO 152020 (Cmax)

    Time frame: 0 to 24 hours postdose for each applicable treatment

  10. Time to maximum plasma concentration of LEO 152020 (tmax)

    Time frame: 0 to 24 hours postdose for each applicable treatment

  11. Area under the plasma concentration-time curve from time 0 to 24 hours postdose of LEO 152020 (AUC0-24).

    Time frame: 0 to 24 hours postdose for each applicable treatment

  12. Area under the plasma concentration-time curve from time 0 to the time of last observed quantifiable concentration of LEO 152020 (AUC0-tlast)

    Time frame: 0 to 24 hours postdose for each applicable treatment

  13. Area under the plasma concentration-time curve from time 0 extrapolated to infinity of LEO 152020 (AUC0-∞)

    Time frame: 0 to 24 hours postdose for each applicable treatment

  14. Apparent terminal elimination half-life of LEO 152020 (t1/2)

    Time frame: 0 to 24 hours postdose for each applicable treatment

  15. Apparent total plasma clearance of LEO 152020 (CL/F)

    Time frame: 0 to 24 hours postdose for each applicable treatment

  16. Apparent volume of distribution during the terminal phase (Vz/F)

    Time frame: 0 to 24 hours postdose for each applicable treatment

  17. Number of treatment-emergent adverse events (AEs)

    Time frame: Dosing on Day 1 of Treatment Period 1 to follow-up. (Up to 17 days)

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Collaborators

  • LEO Pharma

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2022
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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