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

LEO Pharma

Status and phase: Completed; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo capsule; Drug: Delgocitinib capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05050279

LP0133-1409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Delgocitinib placebo capsule

Treatment:

Drug: Placebo capsule

Active dose 1

Experimental group

Description:

Delgocitinib capsule (Dose 1)

Treatment:

Drug: Delgocitinib capsule

Active dose 2

Experimental group

Description:

Delgocitinib capsule (Dose 2)

Treatment:

Drug: Delgocitinib capsule

Active dose 3

Experimental group

Description:

Delgocitinib capsule (Dose 3)

Treatment:

Drug: Delgocitinib capsule

Active dose 4

Experimental group

Description:

Delgocitinib capsule (Dose 4)

Treatment:

Drug: Delgocitinib capsule