A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral VX‑708 in Healthy Subjects
IRAS ID
1004536
Contact name
Alexander Craft
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2021-005559-35
Research summary
The purpose of this study is to look at the development of another way of managing pain. VX-708 is being developed for the treatment of pain, as it has been shown to inhibit (reduce) pain signaling. This is a 2-part, first-in-human study evaluating single ascending (increasing) doses (SAD; Part A) and multiple ascending doses (MAD; Part B) of oral VX-708 in healthy subjects. Approximately 110 subjects will be enrolled (approximately 60 subjects in Part A and approximately 50 subjects in Part B). Part A will also include a Food Effect group whereby the effects of the intake of food on the study drug will also be assessed. The study duration for all Part A Cohorts Except Food Effect Cohort will be 10 days (Treatment Period), plus a Safety Follow-up Visit 12 to 15 days after the last dose of study drug. For the Food Effect Cohort, it will be 19 days (Treatment Periods 1 and 2), plus a Safety Follow-up Visit 12 to 15 days after the last dose of study drug. The study duration for Part B will be 15 days (Treatment Period), plus a Safety Follow-up Visit 12 to 15 days after the last dose of study drug.\n\nHealthy subjects (male and female of non-childbearing potential), 18 through 55 years of age, inclusive will be recruited, and the study will be run in a Phase I Unit within the UK.\n\nLay Summary of Results\n\nLay summary of study results\tA lay summary is not available.\nHas the registry been updated to include summary results?\tNo\nIf yes - please enter the URL to summary results\tn/a\nIf no – why not?\tThe Sponsor do not plan to update the summary results in clinicaltrial.gov as this is a first in human healthy volunteer study.\nDid you follow your dissemination plan submitted in the IRAS application form (Q A51)?\tNo\nIf yes, describe or provide URLs to disseminated materials\tn/a\nIf pending, date when dissemination is expected\tn/a\nIf no, explain why you didn’t follow it\tN/A\nHave participants been informed of the results of the study?\tNo\nIf yes, describe and/or provide URLs to materials shared and how they were shared\tn/a\nIf pending, date when feedback is expected\tn/a\nIf no, explain why they haven’t\tThis is a Phase 1 healthy volunteer study to investigate the safety and tolerability rather than the efficacy of the investigational medicinal product.\nHave you enabled sharing of study data with others?\tNo\nIf yes, describe or provide URLs to how it has been shared\tn/a\nIf no, explain why sharing hasn’t been enabled\tThis is a Phase 1 healthy volunteer study to investigate the safety and tolerability rather than the efficacy of the investigational medicinal product.\nHave you enabled sharing of tissue samples and associated data with others?\tNo\nIf yes, describe or provide a URL\tn/a\nIf no, explain why\tThis is a Phase 1 healthy volunteer study to investigate the safety and tolerability rather than the efficacy of the investigational medicinal product.\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0042
Date of REC Opinion
18 Feb 2022
REC opinion
Further Information Favourable Opinion