Healthy
Conditions
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.
Interventions
DRUGDelgocitinib capsule
oral capsule
DRUGPlacebo capsule
oral capsule
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline QTcF (ΔQTcF) | predose to 24 hours postdose | Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Placebo-corrected change from baseline QTcF (ΔΔQTcF) | predose to 24 hours postdose | Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔQTc interval will be extracted from the continuous digital 12-lead ECG recording |
| Change from baseline of Heart Rate (ΔHR) | predose to 24 hours postdose | Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔHR interval will be extracted from the continuous digital 12-lead ECG recording |
| Placebo-corrected, change from baseline of Heart Rate (ΔΔHR) | predose to 24 hours postdose | Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔΔHR interval will be extracted from the continuous digital 12-lead ECG recording |
| Change from baseline of Pulse Rate (ΔPR) | predose to 24 hourse postdose | Measurement of PR will be performed manually from electrocardiograms (ECGs). |
| Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR) | predose to 24 hours postdose | Measurement of PR will be performed manually from electrocardiograms (ECGs). |
| Change from baseline of QRS interval (ΔQRS) | predose to 24 hours postdose | Measurement of QRS will be performed manually from electrocardiograms (ECGs). |
| Placebo-corrected, change from baseline of QRS interval (ΔΔQRS) | predose to 24 hours postdose | Measurement of QRS will be performed manually from electrocardiograms (ECGs). |
| Frequency of treatment emergent changes in T-wave morphology. | predose to 24 hours postdose | Measurement of T-wave morphology will be performed manually |
| Frequency of treatment emergent changes in U-waves presence | predose to 24 hours postdose | Measurement of U-waves presence will be performed manually |
| Categorical outliers for QTcF, HR, PR interval, and QRS duration. | predose to 24 hours post-dose | Analysis perfomed for changes in categorical outlines based on treatment emergent adverse events. |
| Number of treatment emergent adverse events | dosing to day 15 | — |
Countries
United Kingdom
Contacts
STUDY_DIRECTORMedical Expert
LEO Pharma
Outcome results
None listed