A Phase 1 interventional study of LPM3770164 sustained release tablet in Huntington Disease and Tardive Dyskinesia, sponsored by Luye Pharma Group Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.
270 studies on the registry are indexed under Dyskinesias; 41 are open to participants now.
This study's enrollment of 16 is below the median of 44 across 192 interventional studies indexed under Dyskinesias.
Browse Dyskinesias studies →Luye Pharma Group Ltd. is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fed condition
Drug: LPM3770164 sustained release tablet
Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fasted condition
Drug: LPM3770164 sustained release tablet
Single-dose of 30 mg of LPM3770164 sustained release tablet
Also known as: LY03015
Peak Plasma Concentration (Cmax)
Time frame: Predose and up to 240 hours postdose
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: Predose and up to 240 hours postdose
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Predose and up to 240 hours postdose
Treatment-emergent adverse event
Time frame: from baseline to day 25
Time to maximum concentration (Tmax)
Time frame: Predose and up to 240 hours postdose
Half-life (t1/2)
Time frame: Predose and up to 240 hours postdose
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Luye Pharma Group Ltd.