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

NCT05508776 | Completed Phase 1 FDA Drug

• 2 other identifiers: LP0190-2212U1111-1279-4625
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Predose up to 24 hours postdose for each applicable treatment

Secondary Outcomes (17)

• Change from baseline of Heart Rate (ΔHR)

  Predose up to 24 hours postdose for each applicable treatment

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

  Predose up to 24 hours postdose for each applicable treatment

• Change from baseline of Pulse Rate (ΔPR)

  Predose up to 24 hours postdose for each applicable treatment

• Change from baseline of QRS interval (ΔQRS)

  Predose up to 24 hours postdose for each applicable treatment

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

  Predose up to 24 hours postdose for each applicable treatment

Study Arms (4)

LEO 152020 Dose A

EXPERIMENTAL

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

Drug: LEO 152020

LEO 152020 Dose B

EXPERIMENTAL

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

Drug: LEO 152020

Moxifloxacin

ACTIVE COMPARATOR

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

Drug: Moxifloxacin

Placebo

PLACEBO COMPARATOR

A single dose of placebo according to the randomization schedule.

Drug: Placebo

Interventions

LEO 152020 DRUG

Film-coated tablet Route of administration: Orally 50 mg tablets

LEO 152020 Dose A; LEO 152020 Dose B

Moxifloxacin DRUG

Tablet (may be film-coated depending on brand) Route of administration: Orally 400 mg tablet

Moxifloxacin

Placebo DRUG

Film-coated tablet Route of administration: Orally No active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JW Pharmaceutical: lead
• LEO Pharma: collaborator

Study Sites (1)

LEO Investigational Site

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: September 16, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Data sharing is subject to approved scientifically sound research proposal and signed data agreement

Locations

GB (1)