Concentration‐QTc analysis of soticlestat in healthy adults: An alternative to a thorough QT study
There was no evidence for QT prolongation with soticlestat at therapeutic doses or in two scenarios of high clinical exposures, which resulted in regulatory agencies waiving requirements of a thorough QT study. Safety/PK findings aligned with previous soticlestat clinical studies.
Authors
- Mahnaz Asgharnejad (ORCID: https://orcid.org/0000-0001-8060-2148)
- Nobuhito Dote
- Hiroyuki Fukase (ORCID: https://orcid.org/0000-0002-9488-0947)
- Manami Imazaki
- Wei Yin (ORCID: https://orcid.org/0000-0002-4834-5783)
- Hongqi Xue
- Börje Darpö
- Shin‐ichi Takeda (ORCID: https://orcid.org/0000-0003-0152-1150)
- Kohei Shimizu
Institutions
- Clarion University (US)
- Tokyo Medical University Hospital (JP)
- Takeda (United States) (US)
- Takeda (Japan) (JP)
Publication Details
- Journal
- British Journal of Clinical Pharmacology
- Published
- 2024-09-23
- DOI
- https://doi.org/10.1111/bcp.16255
- Citations
- 1
- Primary Topic
- RNA regulation and disease
- Type
- article
- Field-Weighted Citation Impact
- 0.23
Funders
- Takeda Pharmaceuticals U.S.A.
- Takeda Canada