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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2022-01-04

Brief Summary

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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.

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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes