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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo capsule; Drug: Delgocitinib capsule

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Labcorp Clinical Research Unit (CRU) Ltd, Springfield House, Hyde Street,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Delgocitinib placebo capsule	Drug: Placebo capsule; oral capsule
Experimental: Active dose 1; Delgocitinib capsule (Dose 1)	Drug: Delgocitinib capsule; oral capsule
Experimental: Active dose 2; Delgocitinib capsule (Dose 2)	Drug: Delgocitinib capsule; oral capsule
Experimental: Active dose 3; Delgocitinib capsule (Dose 3)	Drug: Delgocitinib capsule; oral capsule
Experimental: Active dose 4; Delgocitinib capsule (Dose 4)	Drug: Delgocitinib capsule; oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): January 4, 2022
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: LP0133-1409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• IPD Sharing Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No