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This study was a non-randomized, open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography (PET)
This trial adopts a single-center, non-randomized, open-label design, with a planned enrollment of 16 healthy subjects. The LV232 capsule groups include 6 subjects in the 40 mg dose group, 4 subjects in the 60 mg dose group, and 4 subjects in the 20 mg dose group. Additionally, there are 2 subjects in the escitalopram oxalate tablet (positive control drug) group. Based on the results of the LV232 capsule study, the investigator and sponsor will jointly decide whether to proceed with the positive control group, using escitalopram oxalate tablets at a dose of 20 mg as the positive control drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LV232 | Experimental | A single oral dose of 40mg LV232 (5 mg/capsule, 8 capsules each time) ,administrated in fasting state, with 240 mL water to take A single oral dose of 60mg LV232 (5 mg/capsule, 12 capsules each time) ,administrated in fasting state, with 240 mL water to take A single oral dose of 20mg LV232 (5 mg/capsule, 4 capsules each time) ,administrated in fasting state, with 240 mL water to take |
|
| Escitalopram | Active Comparator | A single oral dose of 20mg Escitalopram (10 mg/tablet, 2 tablets each time) , administrated with 240 mL water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LV232 40mg | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Serotonin Transporters occupancy | Percentage of Serotonin Transporters Occupancy in Human Brain after oral LV232 capsule | baseline and 3 hours after administration on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs). | Incidence of treatment-emergent adverse events (TEAEs) | Up to Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yifeng SHEN, MD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center Ethics Committee | Shanghai | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Escitalopram 20 mg |
| Drug |
oral |
|
|
| LV232 60mg | Drug | oral |
|
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| LV232 20mg | Drug | oral |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |