3-part safety, tolerability and PK study of Leo 32731 formulations
Research type
Research Study
Full title
A phase 1, 3-part, single (open-label) and multiple (double-blind, placebo-controlled) oral dose trial to evaluate the safety, tolerability, and pharmacokinetics of LEO 32731 formulations in healthy subjects
IRAS ID
251366
Contact name
Almazedi Firas
Contact email
Sponsor organisation
Leo Pharma A/S
Eudract number
2018-003282-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
18/LO/1864, REC Reference; 251366, IRAS number
Duration of Study in the UK
0 years, 5 months, 14 days
Research summary
LEO 32731 is a phosphodiesterase 4 inhibitor being developed for the treatment of psoriasis.
Psoriasis is a multisystem disease with predominantly skin and joint manifestations, affecting 1% to 3% of the population, characterised by well demarcated, red, scaly plaques, often itchy.
Plaque psoriasis can be managed by topical, photo, or systemic therapy, or a combination. For these patients, systemic agents or phototherapy is the regimen of choice.
The long-term treatment of psoriasis with biological therapies (e.g. antibodies) is limited by safety and tolerability issues, reduced efficacy over time, and poor adherence due to an inconvenient route of administration (e.g. injection).
The concern about biological agents are the effects of long term chronic immunosuppression which has the potential to increase infection and risk of cancer. Therefore, there is an unmet need for safe and effective, long term oral treatments for patients with moderate to severe psoriasis.
This is a phase 1, 3-part, single (open-label) and multiple (double-blind, placebo controlled) oral dose trial to evaluate the safety, tolerability, and PK of LEO 32731 formulations in healthy subjects.
78 subjects will take part in this trial.
In part 1, 36 subjects will take part in 2 groups. Part 2 will have 18 subjects in 2 groups and in part 3 there will be 24 subjects in 2 groups.
Part 1 will evaluate the relative bioavailability (the amount of drug absorbed following administration) of single doses of 4 test formulations of LEO 32731 compared to a reference formulation.
Part 2 will evaluate the effect of food on selected test formulations of LEO 32731. Part 3 will evaluate the tolerability and safety of selected test formulations of LEO 32731 after multiple dosing.
No formulation will be tested in Part 2 and 3 that hasn’t already been evaluated in Parts 1 and 2, respectively.REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1864
Date of REC Opinion
4 Jan 2019
REC opinion
Further Information Favourable Opinion