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.

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.

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.