A Phase 1 interventional study of LPM3770164 sustained release tablet and LPM3770164 sustained release tablet simulant in Tardive Dyskinesia and Huntington Disease, 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 single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical trials.
59 studies on the registry are indexed under Tardive Dyskinesia; 9 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 49 interventional studies indexed under Tardive Dyskinesia.
Browse Tardive Dyskinesia 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:
LPM3770164 sustained-release tablets will be administrated with multiple doses from 5mg to 30mg on day 1\~10
Drug: LPM3770164 sustained release tablet
LPM3770164 sustained release tablet simulant will be administrated on day 1\~10
Drug: LPM3770164 sustained release tablet simulant
administrated orally
administrated orally
Treatment-emergent adverse event
Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Time frame: from baseline to day 37
Peak Plasma Concentration (Cmax)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 to 24 hours (AUC0-24)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: from day 1 to day 24
Time to maximum concentration (Tmax)
Time frame: from day 1 to day 24
Half-life (t1/2)
Time frame: from day 1 to day 24
ECG QTc Interval
Time frame: from baseline to day 37
Ran from Dec 2023 to primary completion in Jul 2024, 7 months.
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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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Studies of the drug tested here: LPM3770164