HealthyEarly Phase 1NCT05050279
A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People
A Early Phase 1 study testing Delgocitinib capsule in people with Healthy, run by LEO Pharma at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Delgocitinib capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2021to 4 Jan 2022
- Phase
- Early 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of ≥18.0 and <30.0 kg/m2.
- In good health, as judged by the investigator based on: medical history, physical examination, vital sign assessment, clinical laboratory evaluations .
- ECG without any clinically relevant abnormal findings at both screening and baseline
- No history of additional risk factors for torsades de pointes (for example, heart failure, hypokalaemia, family history of long QT syndrome).
- Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must be willing to use highlly effective methods of contraception.
Who cannot join
- Any disorder which is not stable and could:
- Affect the safety of the subject throughout the trial.
- Influence the findings of the trial.
- Impede the subject's ability to complete the trial.
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Labcorp Clinical Research Unit (CRU) Ltd, Springfield House, Hyde Street,
Leeds, LS2 9LH
About this study
Official title: A Phase 1 Clinical Trial to Evaluate QTcF Prolongation and Proarrhythmic Potential of the Non Antiarrhythmic Drug Delgocitinib Following Oral Administration in Healthy Subjects
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.
Read the detailed description
The trial will be performed in two parts.
- Part 1: Group 1 (dose 1 or placebo) and Group 2 (dose 2 or placebo)
- Part 2: Group 3 (dose 3 or placebo) and Group 4 (dose 4 or placebo)
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.
- Conditions
- Healthy
- Being tested
- Delgocitinib capsule, Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delgocitinib capsuleDrug
oral capsule
Placebo capsuleDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Delgocitinib placebo capsule Receives: Drug: Placebo capsule |
| Active dose 1 | Experimental | Delgocitinib capsule (Dose 1) Receives: Drug: Delgocitinib capsule |
| Active dose 2 | Experimental | Delgocitinib capsule (Dose 2) Receives: Drug: Delgocitinib capsule |
| Active dose 3 | Experimental | Delgocitinib capsule (Dose 3) Receives: Drug: Delgocitinib capsule |
| Active dose 4 | Experimental | Delgocitinib capsule (Dose 4) Receives: Drug: Delgocitinib capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: predose to 24 hours postdose
Secondary outcomes (11)
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
Measured: predose to 24 hours postdose
Change from baseline of Heart Rate (ΔHR)
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔHR interval will be extracted from the continuous digital 12-lead ECG recording
Measured: 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
Measured: predose to 24 hours postdose
Change from baseline of Pulse Rate (ΔPR)
Measurement of PR will be performed manually from electrocardiograms (ECGs).
Measured: predose to 24 hourse postdose
Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)
Measurement of PR will be performed manually from electrocardiograms (ECGs).
Measured: predose to 24 hours postdose
Change from baseline of QRS interval (ΔQRS)
Measurement of QRS will be performed manually from electrocardiograms (ECGs).
Measured: predose to 24 hours postdose
Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)
Measurement of QRS will be performed manually from electrocardiograms (ECGs).
Measured: predose to 24 hours postdose
Frequency of treatment emergent changes in T-wave morphology.
Measurement of T-wave morphology will be performed manually
Measured: predose to 24 hours postdose
Frequency of treatment emergent changes in U-waves presence
Measurement of U-waves presence will be performed manually
Measured: 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.
Measured: predose to 24 hours post-dose
Number of treatment emergent adverse events
Measured: dosing to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start29 Sep 2021
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050279
- Sponsor's protocol ID
- LP0133-1409
- Status last verified
- Jan 2022
- First submitted
- 5 Jul 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40525591
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate QTcF Prolongation and Proarrhythmic Potential of the Non Antiarrhythmic Drug Delgocitinib Following Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05050279
- Acronym / sponsor ID
- LP0133-1409
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 20 Sep 2021 (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 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.
Detailed description
The trial will be performed in two parts.
- Part 1: Group 1 (dose 1 or placebo) and Group 2 (dose 2 or placebo)
- Part 2: Group 3 (dose 3 or placebo) and Group 4 (dose 4 or placebo)
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo capsuleDelgocitinib placebo capsule |
| Active dose 1 | Experimental | Drug: Delgocitinib capsuleDelgocitinib capsule (Dose 1) |
| Active dose 2 | Experimental | Drug: Delgocitinib capsuleDelgocitinib capsule (Dose 2) |
| Active dose 3 | Experimental | Drug: Delgocitinib capsuleDelgocitinib capsule (Dose 3) |
| Active dose 4 | Experimental | Drug: Delgocitinib capsuleDelgocitinib capsule (Dose 4) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index of ≥18.0 and <30.0 kg/m2.
- In good health, as judged by the investigator based on: medical history, physical examination, vital sign assessment, clinical laboratory evaluations .
- ECG without any clinically relevant abnormal findings at both screening and baseline
- No history of additional risk factors for torsades de pointes (for example, heart failure, hypokalaemia, family history of long QT syndrome).
- Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must be willing to use highlly effective methods of contraception.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Delgocitinib capsuleoral capsule | Drug | Active dose 1, Active dose 2, Active dose 3, Active dose 4 |
| Placebo capsuleoral capsule | Drug | Placebo |
Primary outcome
Change from baseline QTcF (ΔQTcF)
Time frame: predose to 24 hours postdose
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording
11 secondary outcomes
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Time frame: predose to 24 hours postdose
Change from baseline of Heart Rate (ΔHR)
Time frame: predose to 24 hours postdose
Placebo-corrected, change from baseline of Heart Rate (ΔΔHR)
Time frame: predose to 24 hours postdose
Change from baseline of Pulse Rate (ΔPR)
Time frame: predose to 24 hourse postdose
Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)
Time frame: predose to 24 hours postdose
Change from baseline of QRS interval (ΔQRS)
Time frame: predose to 24 hours postdose
Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)
Time frame: predose to 24 hours postdose
Frequency of treatment emergent changes in T-wave morphology.
Time frame: predose to 24 hours postdose
Frequency of treatment emergent changes in U-waves presence
Time frame: predose to 24 hours postdose
Categorical outliers for QTcF, HR, PR interval, and QRS duration.
Time frame: predose to 24 hours post-dose
Number of treatment emergent adverse events
Time frame: dosing to day 15
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 28 Apr 2026.
- Derived from this study: PubMed 40525591Thaci 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.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing Delgocitinib capsule in people with Healthy, run by LEO Pharma 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 5 inclusion and 11 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 28 Apr 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change from baseline QTcF (ΔQTcF) (time frame: predose to 24 hours postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05050279, which also lists 1 linked publication.
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 28 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.