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The purpose of this trial is to investigate the effects of delgocitinib, taken as a capsule, on the heart rhythms of healthy people, compared to a placebo.
The trial will be performed in two parts.
The doses in Part 2 may be adjusted depending on the results of Part 1.
Participants will be screened within 28 days of their dose. Participants will stay in the clinic from Day -1 to Day 2 (1 day postdose) and will be dosed on Day 1. A follow up phone call will take place 2 week (±2 days) after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Delgocitinib placebo capsule |
|
| Active dose 1 | Experimental | Delgocitinib capsule (Dose 1) |
|
| Active dose 2 | Experimental | Delgocitinib capsule (Dose 2) |
|
| Active dose 3 | Experimental | Delgocitinib capsule (Dose 3) |
|
| Active dose 4 | Experimental | Delgocitinib capsule (Dose 4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib capsule | Drug | oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline QTcF (ΔQTcF) | Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording | predose to 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected change from baseline QTcF (ΔΔQTcF) | Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔQTc interval will be extracted from the continuous digital 12-lead ECG recording | predose to 24 hours postdose |
| Change from baseline of Heart Rate (ΔHR) |
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Inclusion Criteria:
Exclusion Criteria:
Any disorder which is not stable and could:
Use of any medication known to prolong the QT/QTc interval within 3 months or 5 half-lives of the drug, whichever is longer, prior to randomisation.
Any medications, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to dosing.
Current use of combined hormone contraceptives or combined hormonal replacement therapy.
Subjects who have smoked (use of any type of tobacco and nicotine containing products) within the last 3 months prior to screening.
History of chronic alcohol or drug abuse within 12 months prior to screening.
Receipt of any vaccine approved for SARS-CoV-2 within 4 weeks prior to baseline and/or 2 weeks after dose.
Receipt of live, attenuated vaccines within 4 weeks prior to baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit (CRU) Ltd, Springfield House, Hyde Street, | Leeds | LS2 9LH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40525591 | Derived | Thaci D, Gooderham M, Lovato P, Madsen DE, Soehoel A, Bissonnette R. Systemic exposure and bioavailability of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema. J Eur Acad Dermatol Venereol. 2025 Sep;39(9):1612-1621. doi: 10.1111/jdv.20777. Epub 2025 Jun 17. |
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| ID | Term |
|---|---|
| C000621572 | delgocitinib |
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| Placebo capsule | Drug | oral capsule |
|
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔHR interval will be extracted from the continuous digital 12-lead ECG recording |
| predose to 24 hours postdose |
| Placebo-corrected, change from baseline of Heart Rate (ΔΔHR) | Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔHR interval will be extracted from the continuous digital 12-lead ECG recording | predose to 24 hours postdose |
| Change from baseline of Pulse Rate (ΔPR) | Measurement of PR will be performed manually from electrocardiograms (ECGs). | predose to 24 hourse postdose |
| Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR) | Measurement of PR will be performed manually from electrocardiograms (ECGs). | predose to 24 hours postdose |
| Change from baseline of QRS interval (ΔQRS) | Measurement of QRS will be performed manually from electrocardiograms (ECGs). | predose to 24 hours postdose |
| Placebo-corrected, change from baseline of QRS interval (ΔΔQRS) | Measurement of QRS will be performed manually from electrocardiograms (ECGs). | predose to 24 hours postdose |
| Frequency of treatment emergent changes in T-wave morphology. | Measurement of T-wave morphology will be performed manually | predose to 24 hours postdose |
| Frequency of treatment emergent changes in U-waves presence | Measurement of U-waves presence will be performed manually | predose to 24 hours postdose |
| Categorical outliers for QTcF, HR, PR interval, and QRS duration. | Analysis perfomed for changes in categorical outlines based on treatment emergent adverse events. | predose to 24 hours post-dose |
| Number of treatment emergent adverse events | dosing to day 15 |