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

• Status: Recruiting
• Trial end date: 2021-12-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LEO Pharma

Criteria

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.