NCT06476509

A Study to Assess Serotonin Transporter Occupancy of Healthy Adults Using 11C-DASB PET

A Non-Randomized, Open-Label, Exploratory Mechanistic Validation (PoM) Clinical Trial of LV232 Capsule Assessing Serotonin Transporter Occupancy in the Healthy Adult Brain Using 11C-DASB Positron Emission Tomography (PET)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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)

Detailed description

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	LV232 40mg	oral
DRUG	Escitalopram 20 mg	oral
DRUG	LV232 60mg	oral
DRUG	LV232 20mg	oral

Timeline

• Start date: 2024-05-30
• Primary completion: 2025-01-19
• Completion: 2025-05-23
• First posted: 2024-06-26
• Last updated: 2025-06-10

Locations

1 site across 1 country: China