Clinical trial NCT05050279: A Trial to Evaluate the Effect of Delgocitinib on the Heart Rhythm of Healthy People
Official title: A Phase 1 Clinical Trial to Evaluate QTcF Prolongation and Proarrhythmic Potential of the Non Antiarrhythmic Drug Delgocitinib Following Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline QTcF (ΔQTcF)
timeFrame: predose to 24 hours postdose
Secondary outcomes:
measure: Placebo-corrected change from baseline QTcF (ΔΔQTcF)
timeFrame: predose to 24 hours postdose
measure: Change from baseline of Heart Rate (ΔHR)
timeFrame: predose to 24 hours postdose
measure: Placebo-corrected, change from baseline of Heart Rate (ΔΔHR)
timeFrame: predose to 24 hours postdose
measure: Change from baseline of Pulse Rate (ΔPR)
timeFrame: predose to 24 hourse postdose
measure: Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)
timeFrame: predose to 24 hours postdose
measure: Change from baseline of QRS interval (ΔQRS)
timeFrame: predose to 24 hours postdose
measure: Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)
timeFrame: predose to 24 hours postdose
measure: Frequency of treatment emergent changes in T-wave morphology.
timeFrame: predose to 24 hours postdose
measure: Frequency of treatment emergent changes in U-waves presence
timeFrame: predose to 24 hours postdose
measure: Categorical outliers for QTcF, HR, PR interval, and QRS duration.
timeFrame: predose to 24 hours post-dose
measure: Number of treatment emergent adverse events
timeFrame: dosing to day 15
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Labcorp Clinical Research Unit (CRU) Ltd, Springfield House, Hyde Street,
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: