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Lookup NU author(s): Dan AstleyORCiD, Dr Shelby BarnettORCiD, Professor Gareth VealORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2026 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. Background: HTL0039732 (HTL) is a novel E-type prostanoid receptor 4 (EP4) antagonist for the treatment of advanced solid tumors. An analytical method was developed to facilitate the analysis of patient samples as part of an ongoing Phase I/IIa clinical trial. Methods and results: A LC-MS/MS method for quantifying HTL in human plasma was developed and validated per regulatory guidelines. The assay was selective, with a 2 ng/mL detection limit observed. It demonstrated good precision (CV ≤11.9%) and accuracy (86–101%), with linearity from 10 to 2000 ng/mL. Recovery was consistent, and no significant matrix, anticoagulant, or carryover effects were observed. Conclusions: A sensitive and selective method for measuring HTL in human plasma was successfully developed and applied to clinical samples, generating first‑in‑human pharmacokinetic data for HTL. The assay is now being utilized in an early‑phase clinical trial setting. Clinical trial registration: https://clinicaltrials.gov/study/NCT05944237.
Author(s): Astley D, Svetlik S, Barnett S, Veal GJ
Publication type: Article
Publication status: Published
Journal: Bioanalysis
Year: 2026
Pages: Epub ahead of print
Online publication date: 06/08/2026
Acceptance date: 28/07/2026
Date deposited: 17/08/2026
ISSN (print): 1757-6180
ISSN (electronic): 1757-6199
Publisher: Taylor and Francis Ltd
URL: https://doi.org/10.1080/17576180.2026.2712785
DOI: 10.1080/17576180.2026.2712785
Data Access Statement: The data that support the findings of this study are available from the corresponding author (GV) upon reasonable request.
PubMed id: 42558019
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