Evaluation of QTcF Delgocitinib in healthy subjects

• Research type

  Research Study

• Full title

  A phase 1 clinical trial to evaluate QTcF prolongation and proarrhythmic potential of the non anti arrhythmic drug delgocitinib following oral administration in healthy subjects.

• IRAS ID

  277844

• Contact name

  Jim Bush

• Contact email

  Jim.Bush@labcorp.com

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2020-000542-33

• Clinicaltrials.gov Identifier

  NCT05050279

• Clinicaltrials.gov Identifier

  Rec ref, 20/NE/0026

• Duration of Study in the UK

  0 years, 2 months, 8 days

• Research summary

  Summary of Research
  Delgocitinib cream is a formulation developed by LEO Pharma A/S (“LEO Pharma”) for further clinical development for the main indications atopic dermatitis and chronic hand eczema. Delgocitinib was originally formulated in an ointment but has also been developed an oral tablet formulation (delgocitinib tablet). Delgocitinib tablet was used in early clinical development and no further development is pursued for this administration form.

  This will be a randomised, double-blind, placebo-controlled, parallel-group, single-dose, single-centre study to evaluate QTcF prolongation and pro-arrhythmic potential for the non-arrhythmic drug delgocitinib following oral administration in healthy subjects. A capsule formulation of delgocitinib will be used which is expected to show rapid absorption following oral administration similar to the delgocitinib tablet.

  The study includes the following parts:
  • A screening visit from 2 days to 28 days before the first dose of delgocitinib.
  • An in-clinic treatment period of 2 days. Eligible subjects will be randomised at check-in (Day 1) to treatment with either delgocitinib capsule or delgocitinib capsule placebo.
  • A safety follow-up visit at 1 week (±2 days) after dosing (follow-up may be via phone call).

  Part 1 will establish the relationship between dose and exposure (how much of the drug gets into the blood stream) for the delgocitinib capsule, 2 dose cohorts will be evaluated before initiating the subsequent cohorts. Each cohort will consist of 8 subjects receiving active treatment (delgocitinib capsule) and 2 subjects receiving placebo treatment (delgocitinib capsule placebo): 6 mg (cohort A) and 12 mg (cohort B). All subjects will receive the active or placebo formulations as a single oral administration.

  For Part 2, each cohort will consist of 8 subjects receiving active treatment (delgocitinib capsule) and 2 subjects receiving placebo treatment (delgocitinib capsule placebo) The planned doses are3 mg (cohort C), and 1.5 mg (cohort D). All subjects will receive the active or placebo formulations as a single oral administration. Time points for PK blood sampling and continuous ECG monitoring are the same as described for Part 1.
  The anticipated minimum number of randomised subjects is 40.

  Summary of Results
  LEO will publish the study results by way of the project lay summary in April 2023. This can be found on the LEO Homepage once uploaded by the Sponsor here: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DGMTRiqbfL20AK5-2BZC2DdJE4sDSLsBSXPWTZxEMeFTBwsEZZRfOSe-2BFwKdzjAf3mi_F9b_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJeq3Rb-2FpUiCmdJtO4X6gdlAJt1gSmea6J5regH-2BXN3DnhT-2BOpVqzx4tYSvo1I-2FTYI40yg4kN08PJAT5191alDNJcUJPSGxwrghiA8MZtNIsZ6t6bhbb9uN7Ut4Ft3kd3JWiYWMCnu0z-2B-2FNKHXmbkhq6ycuEyIlKS-2BpsW5AB891oQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C0d97df0acb2449b9f59d08db2f6e3478%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638155922591692184%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=LuiO2ryIvY43%2B5Iv8ZFPixnBjRXZohgR90EkQcFZXl0%3D&reserved=0

• REC name

  North East - York Research Ethics Committee

• REC reference

  20/NE/0026

• Date of REC Opinion

  9 Apr 2020

• REC opinion

  Favourable Opinion