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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1279-4625 | Other Identifier | World Health Organization (WHO) |
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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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The trial medicine (LEO 152020) is being developed to treat people with eczema.
The aims of this trial are to find out about:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 152020 Dose A | Experimental | A single oral dose of LEO 152020 Dose A according to the randomization schedule. |
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| LEO 152020 Dose B | Experimental | A single dose of LEO 152020 Dose B according to the randomization schedule. |
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| Moxifloxacin | Active Comparator | A single oral dose of moxifloxacin 400 mg according to the randomization schedule. |
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| Placebo | Placebo Comparator | A single dose of placebo according to the randomization schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 152020 | Drug | Film-coated tablet Route of administration: Orally 50 mg tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose up to 24 hours postdose for each applicable treatment |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Investigational Site | Leeds | LS2 9LH | United Kingdom |
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Data sharing is subject to approved scientifically sound research proposal and signed data agreement
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Tablet (may be film-coated depending on brand) Route of administration: Orally 400 mg tablet |
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| Placebo | Drug | Film-coated tablet Route of administration: Orally No active ingredient |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Predose up to 24 hours postdose for each applicable treatment |
| Maximum observed plasma concentration of LEO 152020 (Cmax) | 0 to 24 hours postdose for each applicable treatment |
| Time to maximum plasma concentration of LEO 152020 (tmax) | 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). | 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) | 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-∞) | 0 to 24 hours postdose for each applicable treatment |
| Apparent terminal elimination half-life of LEO 152020 (t1/2) | 0 to 24 hours postdose for each applicable treatment |
| Apparent total plasma clearance of LEO 152020 (CL/F) | 0 to 24 hours postdose for each applicable treatment |
| Apparent volume of distribution during the terminal phase (Vz/F) | 0 to 24 hours postdose for each applicable treatment |
| Number of treatment-emergent adverse events (AEs) | Dosing on Day 1 of Treatment Period 1 to follow-up. (Up to 17 days) |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |