A Phase 1 interventional study of LY03017 and LY03017-Placebo in Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis and Negative Symptoms of Schizophrenia, sponsored by Luye Pharma Group Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment
This is a phase 1,randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects.
135 studies on the registry are indexed under Hallucinations; 36 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 115 interventional studies indexed under Hallucinations.
Browse Hallucinations studies →Luye Pharma Group Ltd. is the lead sponsor of 74 studies on the registry; 15 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Ascending single oral doses of LY03017 in healthy adult subjects
Drug: LY03017
LY03017-Placebo
Drug: LY03017-Placebo
single dose, administered orally
Also known as: LPM526000133 Fumarate Capsules
single dose, administered orally
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to 216 hours
Maximum observed concentration (Cmax) of LPM526000133 in plasma
Time frame: up to 216 hours
Time to maximum observed concentration (Tmax) of LPM526000133 in plasma
Time frame: up to 216 hours
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma
Time frame: up to 216 hours
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma
Time frame: up to 216 hours
Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma
Time frame: up to 216 hours
Start is estimated for May 2024; primary completion for Mar 2025, 10 months later.
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This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: LY03017