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

Early Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Delgocitinib capsule; Drug: Placebo capsule

• Registration Number: NCT05050279
• Lead Sponsor: LEO Pharma

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.

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 Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Study Start: 2021-09-29
• Status Verified: 2022-01
• Primary Completion: 2022-01-04
• Study Completion: 2022-01-04
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active dose 3	Delgocitinib capsule	Delgocitinib capsule (Dose 3)
Active dose 4	Delgocitinib capsule	Delgocitinib capsule (Dose 4)
Placebo	Placebo capsule	Delgocitinib placebo capsule
Active dose 2	Delgocitinib capsule	Delgocitinib capsule (Dose 2)
Active dose 1	Delgocitinib capsule	Delgocitinib capsule (Dose 1)

Primary Outcome Measures

Name	Time	Method
Change from baseline QTcF (ΔQTcF)	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

Secondary Outcome Measures

Name	Time	Method
Frequency of treatment emergent changes in T-wave morphology.	predose to 24 hours postdose	Measurement of T-wave morphology will be performed manually
Placebo-corrected change from baseline QTcF (ΔΔQTcF)	predose to 24 hours postdose	Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔQTc interval will be extracted from the continuous digital 12-lead ECG recording
Placebo-corrected, change from baseline of Heart Rate (ΔΔHR)	predose to 24 hours postdose	Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔHR interval will be extracted from the continuous digital 12-lead ECG recording
Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)	predose to 24 hours postdose	Measurement of PR will be performed manually from electrocardiograms (ECGs).
Change from baseline of Heart Rate (ΔHR)	predose to 24 hours postdose	Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔHR interval will be extracted from the continuous digital 12-lead ECG recording
Change from baseline of Pulse Rate (ΔPR)	predose to 24 hourse postdose	Measurement of PR will be performed manually from electrocardiograms (ECGs).
Change from baseline of QRS interval (ΔQRS)	predose to 24 hours postdose	Measurement of QRS will be performed manually from electrocardiograms (ECGs).
Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)	predose to 24 hours postdose	Measurement of QRS will be performed manually from electrocardiograms (ECGs).
Number of treatment emergent adverse events	dosing to day 15
Frequency of treatment emergent changes in U-waves presence	predose to 24 hours postdose	Measurement of U-waves presence will be performed manually
Categorical outliers for QTcF, HR, PR interval, and QRS duration.	predose to 24 hours post-dose	Analysis perfomed for changes in categorical outlines based on treatment emergent adverse events.

Trial Locations

Locations (1)

Labcorp Clinical Research Unit (CRU) Ltd, Springfield House, Hyde Street,; 🇬🇧 Leeds, United Kingdom