Open-label study to determine bioavailability of two LYS006 capsules
Research type
Research Study
Full title
An open-label, randomized, multiple-dose, crossover study to determine the oral bioavailability of LYS006 delayed release (DR) capsules relative to immediate release (IR) capsules.
IRAS ID
259732
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-004508-20
Duration of Study in the UK
0 years, 1 months, 30 days
Research summary
This is an open-label, randomised, multiple-dose, crossover study to determine the oral bioavailability of LYS006 delayed release capsules relative to immediate release capsules.
The study drug (LYS006) is being developed by the sponsor for treatment of inflammatory acne and ulcerative colitis. LYS006 is a small synthetic molecule, that is formulated as hard gelatin capsules for oral administration. It acts as a highly potent and selective oral inhibitor of an enzyme (protein that works as a catalyst, called LTB4) that promotes the creation of a chemical that drives inflammation in the body. The study drug would therefore inhibit the synthesis of this chemical, reducing inflammatory symptoms for the two indications. For both inflammatory acne and ulcerative colitis, an approximate 70-fold less potent LTB4 inhibitor demonstrated some clinical efficacy, however these specific enzyme inhibitors have not been developed for these two indications yet. Therefore, the study drug would constitute a new therapeutic approach for inflammatory acne and ulcerative colitis.
The main purpose of the study is to determine the way LYS006 is taken up into your body when taken as delayed release capsules relative to immediate release capsules. Delayed release medicines, when administered, do not immediately disintegrate (break down) and release the active drug into the body’s blood stream at a much slower rate for a longer period of time than immediate release medicines. In addition, the study will also test if food has any effect on the absorption of LYS006 delayed release capsules from the intestine (e.g., whether food will decrease the absorption of the drug), and if LYS006 capsule is safe.
The study has a single part in which subjects will be allocated to one of six treatment sequences. This will allow researchers to administer the two formulations of the study drug (immediate release – IR – and delayed release – DR), in varying sequences and different fasting conditions (doses on every day will amount to 20mg). This will determine whether the use of a delayed release hard capsule allows more of the active ingredient to reach the intended target than the immediate release, and, because of its slower onset, if it can reduce the urine concentrations, and therefore risk of crystallization, of LYS006 in urine. All subjects will be domiciled from admission, on Day -1, to discharge, on Day 12. Two follow-up visits on Day 19 and Day 30 are planned.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0492
Date of REC Opinion
25 Apr 2019
REC opinion
Favourable Opinion