* ADME study of [14C]RIST4721 in Healthy Male Volunteers (QSC205477)
Research type
Research Study
Full title
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
IRAS ID
297279
Contact name
Sara McCutchan
Contact email
Sponsor organisation
Aristea Therapeutics Inc.
Eudract number
2021-001574-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
The Sponsor is developing the test medicine, RIST4721, for the potential treatment of inflammatory diseases, for example Palmoplantar pustulosis (PPP).
PPP is a rare and chronic inflammatory skin condition, characterised by repeated outbreaks of blisters on the palms of the hands and/or soles of the feet. There are currently no approved medicines for this disease in the US, EU, or UK.
This study will aim to look at how the test medicine is taken up, broken down and removed by the body when given in liquid form (oral solution). To help investigate how this happens, the test medicine will be radiolabelled. ‘Radiolabelled’ means that the test medicine has a radioactive component (Carbon-14), which enables the test medicine to be tracked throughout its movement in the body. The safety and tolerability of the test medicine will also be studied.
The study will consist of a single study period involving up to 6 healthy male volunteers, aged 30 - 65. Volunteers will be admitted to the clinic the evening before the day of dosing. On Day 1, following an overnight fast of at least 10 hours, volunteers will receive a single 400 mg dose of the radiolabeled test medicine as an oral solution. Blood, urine and faecal samples will be collected throughout the study. Volunteers will remain in the clinic up to Day 17, however if the relevant radioactivity criteria have been met for all volunteers in the study before Day 17, the volunteers may be discharged early as a group. If the relevant radioactivity criteria have not been met by Day 17, volunteers stay may be extended until Day 19. If the criteria are still not met by Day 19 then home collections of urine and/or faeces may be required.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/FT/0067
Date of REC Opinion
14 Jul 2021
REC opinion
Further Information Favourable Opinion