Goldsmith, Paul
Affinito, John
McCue, Maggie
Tsai, Max
Roepcke, Stefan
Xie, Jinhui
Gertsik, Lev
Macek, Thomas A.
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Randomized Multiple Dose Pharmacokinetic Study of a Novel PDE10A Inhibitor TAK-063 in Subjects with Stable Schizophrenia and Japanese Subjects and Modeling of Exposure Relationships to Adverse Events
https://doi.org/10.1007/s40268-017-0214-8
Funding for this research was provided by:
Takeda Development Center Americas, Inc.
Article History
First Online: 4 November 2017
Compliance with Ethical Standards
:
: The clinical study was funded by Takeda Development Center Americas, Inc. Medical writing assistance was provided by Stephanie Agbu, Ph.D, and Jake Edelstein, Ph.D, of inVentiv Medical Communications and supported by Takeda Development Center Americas, Inc.
: John Affinito and Maggie McCue are employees of Takeda Development Center Americas, Inc., Deerfield, IL. At the time the study was conducted, Max Tsai, Jinhui Xie, and Thomas A. Macek were employees of Takeda Development Center Americas, Inc.; Paul Goldsmith was an employee of Takeda Development Centre Europe Ltd., London, UK; and Stefan Roepcke was an employee of Takeda Pharmaceuticals International GmbH, Zürich, Switzerland. Lev Gertsik is an employee of California Clinical Trials Medical Group/Parexel, Glendale, CA, USA. He is a consultant to Takeda.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent was obtained from all individual participants included in the study.
: This study is registered as “Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK-063 in Participants With Stable Schizophrenia and Healthy Participants” (Clinical Trials ID: NCT01879722).