Phase 1 PK study of PCS499 in healthy subjects (QCL118129)
Research type
Research Study
Full title
A Phase I, Single Centre, Open-Label, Non-Randomised Study to Evaluate the Pharmacokinetics of Single and Optional Multiple Dosing Regimens of Modified Release Formulations of PCS499 Compared to Trental® (Pentoxifylline) Administered to Healthy Subjects under Fed Conditions
IRAS ID
236386
Contact name
Sian Bigora
Contact email
Sponsor organisation
Processa Pharmaceuticals
Eudract number
2017-005156-29
Duration of Study in the UK
0 years, 3 months, 11 days
Research summary
The Sponsor is developing the study drug, PCS499, for the potential treatment of Necrobiosis Lipoidica (NL), this is an idiopathic (meaning the cause is unknown) skin condition which can cause ulcers and mainly affects the legs but can also occur on other areas of the body like the face, scalp, forearm and trunk. There is currently no approved medicines to treat NL.
The study will try to identify the pharmacokinetics (how the study drug is taken up by the body) of 4 different formulations (recipes) of the study drug and compare to another medicine, Trental®. Trental is an already approved medicine, used to treat intermittent claudication (painful aches/cramps in the legs when walking due to reduced blood flow), with a break down product that is similar to PCS499. There is evidence Trental may help treat NL.
The study will consist of up to 2 parts involving up to 20 healthy male and female subjects. Part 1 will consist of 4 periods and up to 12 subjects. Each of the subjects will receive one dose at each period, of either Trental or one of the study drug formulations (recipes).
Part 2 will consist of 3 periods and up to 8 subjects. In Period 1, subjects will receive one dose on Days 1 and 4, and 2 doses on Days 2 and 3. In Periods 2 and 3, subjects will receive one dose on Days 1 and 4, and 3 doses on Days 2 and 3. During Periods 1 and 2 subjects will receive different doses of one formulation of the study drug and during Period 3 the subjects will receive doses of Trental. The formulation that will be used during Part 2 will be decided based on the pharmacokinetic and safety data from Part 1.
REC name
HSC REC B
REC reference
18/NI/0021
Date of REC Opinion
20 Feb 2018
REC opinion
Favourable Opinion