Document is current

Article History

Accepted: 16 October 2024

First Online: 8 November 2024

Declarations

:

: This trial was sponsored by Acadia Pharmaceuticals Inc.

: Mona Darwish, Rene Nunez, James M. Youakim, and Di An are employees of and hold stock in Acadia Pharmaceuticals Inc. Kathie M. Bishop is a consultant for Acadia Pharmaceuticals Inc., and former employee. Inger Darling and Viera Lukacova are employees of and hold stock in Simulations Plus, Inc. Thomas C. Marbury is an employee and equity owner of Orlando Clinical Research Center.

: The phase 1 clinical study was approved by an Institutional Review Board and was performed in accordance with Health Insurance Portability and Accountability Act regulations, Food and Drug Administration Good Clinical Practice Regulations, and International Council for Harmonisation Good Clinical Practice Guidelines. All participants provided written informed consent.

: All study participants provided written informed consent.

: Not applicable.

: The datasets generated during and/or analyzed during the current study are not publicly available due to data confidentiality but are available from the corresponding author on reasonable request providing a confidentiality agreement is signed.

: Not applicable.

: Conceptualisation: MD, JMY, and KMB; Methodology: MD, RN, JMY, DA, ID, VL, and KMB; Data curation, formal analysis, investigation, visualisation: MD, TCM, RN, DA, ID, and VL; Writing (original draft/previous versions/approval): MD, TCM, RN, JMY, DA, ID, VL, and KMB.