Phase I Trial (QSC205947)
Research type
Research Study
Full title
A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of VTX958 Adipate Modified Release Tablet Formulations in Healthy Subjects
IRAS ID
1006953
Contact name
Lily Medina
Contact email
Sponsor organisation
Ventyx Biosciences, Inc.
ISRCTN Number
ISRCTN97798065
Research summary
Summary of Research\nThis 6-period healthy volunteer study will assess the performance of new formulations (recipes) of the test medicine when given as single doses and multiple doses. The extent the test medicine is taken up by the body will be measured and the safety and tolerability of the test medicine will be monitored throughout.\nThis study will take place at one non-NHS site, and is planned to enrol 20 male volunteers aged between 18 to 60 years.\nIn Periods 1–3, volunteers will receive a single 150 mg dose of the test medicine (new recipe) as 1 tablet by mouth at each study visit in the fasted (empty stomach) or fed state. \nIn Period 4, volunteers may receive a single 150 mg dose of the test medicine (new recipe) as 1 tablet by mouth (fasted or fed) or may receive the test medicine by mouth on the morning of Days 1-3 (fasted) and Day 4 (fed) as 1 tablet or multiple tablets.\nIn Period 5, volunteers will receive either the test medicine (new recipe) once daily, as 1 tablet or multiple tablets, or the current receipt of the test medicine twice daily (morning and evening), as 2 x125 mg tablets at each dosing occasion, by mouth on Days 1-3 (fasted) and Day 4 (fed).\nIn Period 6 (optional) volunteers will receive the current recipe of the test medicine twice daily (morning and evening), as 2 tablets on each dosing occasion, by mouth on Days 1-3 (fasted) and Day 4 (fed).\nVolunteers will be discharged on Day 3 (Periods 1-3) and Day 6 (Periods 4-6) and will receive a follow up phone call 5 to 7 days post final dose.\nVolunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. \nVolunteers are expected to be involved in this study for approximately 15weeks from screening to the follow up call.\n\nSummary of Results\nAs this is a phase I trial, no lay summary of results has been provided, for reasons of commercial confidentiality.
REC name
Wales REC 2
REC reference
23/WA/0014
Date of REC Opinion
30 Mar 2023
REC opinion
Further Information Favourable Opinion