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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPM3770164 | Experimental | LPM3770164 sustained-release tablets will be administrated with multiple doses from 5mg to 30mg on day 1~10 |
|
| Placebo | Placebo Comparator | LPM3770164 sustained release tablet simulant will be administrated on day 1~10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPM3770164 sustained release tablet | Drug | administrated orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to day 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | from day 1 to day 24 | |
| Area Under the Curve from time 0 to 24 hours (AUC0-24) | from day 1 to day 24 | |
| Area Under the Curve from time 0 to the last measurable concentration (AUC0-t) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huafang Li, Doctor | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D000071057 | Tardive Dyskinesia |
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
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| LPM3770164 sustained release tablet simulant |
| Drug |
administrated orally |
|
| from day 1 to day 24 |
| Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf) | from day 1 to day 24 |
| Time to maximum concentration (Tmax) | from day 1 to day 24 |
| Half-life (t1/2) | from day 1 to day 24 |
| ECG QTc Interval | from baseline to day 37 |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |