A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People (NCT05050279) | Clinical Trial Compass
CompletedEarly Phase 1
A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People
United Kingdom40 participantsStarted 2021-09-29
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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-Co…