A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People

NCT05050279 | Completed Early Phase 1 DMC

• 1 other identifier: LP0133-1409
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Placebo-corrected change from baseline QTcF (ΔΔQTcF)

  predose to 24 hours postdose

• Change from baseline of Heart Rate (ΔHR)

  predose to 24 hours postdose

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

  predose to 24 hours postdose

• Change from baseline of Pulse Rate (ΔPR)

  predose to 24 hourse postdose

• Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)

  predose to 24 hours postdose

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Delgocitinib placebo capsule

Drug: Placebo capsule

Active dose 1

EXPERIMENTAL

Delgocitinib capsule (Dose 1)

Drug: Delgocitinib capsule

Active dose 2

EXPERIMENTAL

Delgocitinib capsule (Dose 2)

Drug: Delgocitinib capsule

Active dose 3

EXPERIMENTAL

Delgocitinib capsule (Dose 3)

Drug: Delgocitinib capsule

Active dose 4

EXPERIMENTAL

Delgocitinib capsule (Dose 4)

Drug: Delgocitinib capsule

Interventions

Delgocitinib capsule DRUG

oral capsule

Active dose 1; Active dose 2; Active dose 3; Active dose 4

Placebo capsule DRUG

oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Labcorp Clinical Research Unit (CRU) Ltd, Springfield House, Hyde Street,

Leeds, LS2 9LH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40525591 DERIVED

MeSH Terms

Interventions

delgocitinib

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: September 20, 2021
• Study Start: September 29, 2021
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: April 28, 2026

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)