NCT05050279

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Delgocitinib capsule	oral capsule
DRUG	Placebo capsule	oral capsule

Timeline

• Start date: 2021-09-29
• Primary completion: 2022-01-04
• Completion: 2022-01-04
• First posted: 2021-09-20
• Last updated: 2025-02-24

Locations

1 site across 1 country: United Kingdom