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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050279
• Other study ID #: LP0133-1409
• Status: Completed
• Phase: Early Phase 1
• Start date: September 29, 2021
• Est. completion date: January 4, 2022

Study information

• Verified date: January 2022
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Delgocitinib capsule
oral capsule
• Placebo capsule
oral capsule

Locations

Country	Name	City	State
United Kingdom	Labcorp Clinical Research Unit (CRU) Ltd, Springfield House, Hyde Street,	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline QTcF (?QTcF)	Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ?QTc interval will be extracted from the continuous digital 12-lead ECG recording	predose to 24 hours postdose
Secondary	Placebo-corrected change from baseline QTcF (??QTcF)	Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ??QTc interval will be extracted from the continuous digital 12-lead ECG recording	predose to 24 hours postdose
Secondary	Change from baseline of Heart Rate (?HR)	Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ?HR interval will be extracted from the continuous digital 12-lead ECG recording	predose to 24 hours postdose
Secondary	Placebo-corrected, change from baseline of Heart Rate (??HR)	Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ??HR interval will be extracted from the continuous digital 12-lead ECG recording	predose to 24 hours postdose
Secondary	Change from baseline of Pulse Rate (?PR)	Measurement of PR will be performed manually from electrocardiograms (ECGs).	predose to 24 hourse postdose
Secondary	Placebo-corrected, change from baseline of Pulse Rate (??PR)	Measurement of PR will be performed manually from electrocardiograms (ECGs).	predose to 24 hours postdose
Secondary	Change from baseline of QRS interval (?QRS)	Measurement of QRS will be performed manually from electrocardiograms (ECGs).	predose to 24 hours postdose
Secondary	Placebo-corrected, change from baseline of QRS interval (??QRS)	Measurement of QRS will be performed manually from electrocardiograms (ECGs).	predose to 24 hours postdose
Secondary	Frequency of treatment emergent changes in T-wave morphology.	Measurement of T-wave morphology will be performed manually	predose to 24 hours postdose
Secondary	Frequency of treatment emergent changes in U-waves presence	Measurement of U-waves presence will be performed manually	predose to 24 hours postdose
Secondary	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
Secondary	Number of treatment emergent adverse events		dosing to day 15