Healthy VolunteersPhase 1NCT05508776
A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People
A Phase 1 study testing LEO 152020 and Moxifloxacin in people with Healthy Volunteers and Cardiac Repolarisation, run by JW Pharmaceutical at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Cardiac Repolarisation
- What is being tested?
- LEO 152020 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2022to 28 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The trial medicine (LEO 152020) is being developed to treat people with eczema.
The aims of this trial are to find out about:
Read more
- 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
- Being tested
- LEO 152020, Moxifloxacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 152020Drug
Film-coated tablet
Route of administration: Orally
50 mg tablets
MoxifloxacinDrug
Tablet (may be film-coated depending on brand)
Route of administration: Orally
400 mg tablet
PlaceboDrug
Film-coated tablet
Route of administration: Orally
No active ingredient
| Study group | Role | What they receive |
|---|---|---|
| LEO 152020 Dose A | Experimental | A single oral dose of LEO 152020 Dose A according to the randomization schedule. Receives: Drug: LEO 152020 |
| LEO 152020 Dose B | Experimental | A single dose of LEO 152020 Dose B according to the randomization schedule. Receives: Drug: LEO 152020 |
| Moxifloxacin | Active comparator | A single oral dose of moxifloxacin 400 mg according to the randomization schedule. Receives: Drug: Moxifloxacin |
| Placebo | Placebo comparator | A single dose of placebo according to the randomization schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change from baseline of LEO 152020 using QT interval corrected using Fridericia's formula (ΔΔQTcF)
Measured: Predose up to 24 hours postdose for each applicable treatment
Secondary outcomes (17)
Change from baseline of Heart Rate (ΔHR)
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Change from baseline of QT interval corrected using Fridericia's formula (ΔQTcF)
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Change from baseline of Pulse Rate (ΔPR)
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Change from baseline of QRS interval (ΔQRS)
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Placebo-corrected, change from baseline of Heart Rate (ΔΔHR)
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Categorical outliers for QTcF, HR, PR interval, and QRS duration
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.
Measured: Predose up to 24 hours postdose for each applicable treatment
Maximum observed plasma concentration of LEO 152020 (Cmax)
Measured: 0 to 24 hours postdose for each applicable treatment
Time to maximum plasma concentration of LEO 152020 (tmax)
Measured: 0 to 24 hours postdose for each applicable treatment
Area under the plasma concentration-time curve from time 0 to 24 hours postdose of LEO 152020 (AUC0-24).
Measured: 0 to 24 hours postdose for each applicable treatment
Area under the plasma concentration-time curve from time 0 to the time of last observed quantifiable concentration of LEO 152020 (AUC0-tlast)
Measured: 0 to 24 hours postdose for each applicable treatment
Area under the plasma concentration-time curve from time 0 extrapolated to infinity of LEO 152020 (AUC0-∞)
Measured: 0 to 24 hours postdose for each applicable treatment
Apparent terminal elimination half-life of LEO 152020 (t1/2)
Measured: 0 to 24 hours postdose for each applicable treatment
Apparent total plasma clearance of LEO 152020 (CL/F)
Measured: 0 to 24 hours postdose for each applicable treatment
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: 0 to 24 hours postdose for each applicable treatment
Number of treatment-emergent adverse events (AEs)
Measured: Dosing on Day 1 of Treatment Period 1 to follow-up. (Up to 17 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start16 Sep 2022
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508776
- Sponsor's protocol ID
- LP0190-2212
- Other IDs
- U1111-1279-4625
- Status last verified
- Apr 2024
- First submitted
- 18 Aug 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05508776
- Acronym / sponsor ID
- LP0190-2212
- Conditions
- Healthy Volunteers, Cardiac Repolarisation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- LEO Pharma
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEO 152020 Dose A | Experimental | Drug: LEO 152020A single oral dose of LEO 152020 Dose A according to the randomization schedule. |
| LEO 152020 Dose B | Experimental | Drug: LEO 152020A single dose of LEO 152020 Dose B according to the randomization schedule. |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinA single oral dose of moxifloxacin 400 mg according to the randomization schedule. |
| Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo according to the randomization schedule. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 152020Film-coated tablet Route of administration: Orally 50 mg tablets | Drug | LEO 152020 Dose A, LEO 152020 Dose B |
| MoxifloxacinTablet (may be film-coated depending on brand) Route of administration: Orally 400 mg tablet | Drug | Moxifloxacin |
| PlaceboFilm-coated tablet Route of administration: Orally No active ingredient | Drug | Placebo |
Primary outcome
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
17 secondary outcomes
Change from baseline of Heart Rate (ΔHR)
Time frame: Predose up to 24 hours postdose for each applicable treatment
Change from baseline of QT interval corrected using Fridericia's formula (ΔQTcF)
Time frame: Predose up to 24 hours postdose for each applicable treatment
Change from baseline of Pulse Rate (ΔPR)
Time frame: Predose up to 24 hours postdose for each applicable treatment
Change from baseline of QRS interval (ΔQRS)
Time frame: Predose up to 24 hours postdose for each applicable treatment
Placebo-corrected, change from baseline of Heart Rate (ΔΔHR)
Time frame: Predose up to 24 hours postdose for each applicable treatment
Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)
Time frame: Predose up to 24 hours postdose for each applicable treatment
Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)
Time frame: Predose up to 24 hours postdose for each applicable treatment
Categorical outliers for QTcF, HR, PR interval, and QRS duration
Time frame: Predose up to 24 hours postdose for each applicable treatment
Maximum observed plasma concentration of LEO 152020 (Cmax)
Time frame: 0 to 24 hours postdose for each applicable treatment
Time to maximum plasma concentration of LEO 152020 (tmax)
Time frame: 0 to 24 hours postdose for each applicable treatment
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
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
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
Apparent terminal elimination half-life of LEO 152020 (t1/2)
Time frame: 0 to 24 hours postdose for each applicable treatment
Apparent total plasma clearance of LEO 152020 (CL/F)
Time frame: 0 to 24 hours postdose for each applicable treatment
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: 0 to 24 hours postdose for each applicable treatment
Number of treatment-emergent adverse events (AEs)
Time frame: Dosing on Day 1 of Treatment Period 1 to follow-up. (Up to 17 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Yes
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 152020 and Moxifloxacin in people with Healthy Volunteers and Cardiac Repolarisation, run by JW Pharmaceutical at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.