This is an open-label, single-dose, parallel-group study to evaluate the safety, tolerability and pharmacokinetic characteristics of LY03015 in healthy Chinese and Caucasian adult subjects. The duration of study will be around up to 42 days for each participant, including up to 14 days of screening period, baseline visit, and a 28-day safety assessment period with a 7-day/6-night stay in the clinical research unit.
A total of 24 subjects (12 Chinese, 12 Caucasians) will be enrolled. A single dose of 20 mg LY03015 will be administered orally under fasting condition. The primary objective is to characterize the pharmacokinetic (PK) profiles of LY03015 following a single oral administration in healthy Chinese and Caucasian adult subjects. The secondary objective is to evaluate the safety and tolerability of a single oral dose of LY03015.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
LY03015 (LPM3770164) is an investigational extended-release tablet administered. LY03015, a new generation dual-target drug is a selective VMAT2 inhibitor and sigma-1 receptor.
Collaborative Neuroscience Research, LLC.
Los Alamitos, California, United States
Pharmacokinetic profile of LY03015
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) and extrapolated to infinity (AUC0-∞) of LY03015
Time frame: 15 days
Pharmacokinetic profile of LY03015
Maximum observed concentration (Cmax) of LY03015
Time frame: 15 days
Safety and tolerability of LY03015
Summary of incidence of adverse events. AE will be monitored throughout the study course
Time frame: 28 days
Evaluate suicidal attempts measured by Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS measures the suicidal intensity of ideation and attempt with score of 1-5; 1 means the least severe and 5 means the most severe.
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.