An Open-Label PET/CT Imaging Study to Evaluate Brain Serotonin Transporter (SERT) Occupancy Following Single-Dose Administration of LG-0317 Tablets in Healthy Participants
NCT07708428 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-07-16
Summary
The purpose of the study is to evaluate brain serotonin transporter (SERT) receptor occupancy (RO) following single oral doses of LG-0317 tablets in healthy male participants; and to explore the pharmacokinetic/pharmacodynamic (PK/PD) relationship between LG-0317 plasma concentrations and SERT occupancy..
Conditions
- Healthy Volunteers (HV)
Interventions
- DRUG
-
Cohort 1: LG-0317 20 mg
Subjects will receive single dose of LG-0317 tablets.
- DRUG
-
Cohort 1: LG-0317 40 mg
Subjects will receive single dose of LG-0317 tablets.
- DRUG
-
Cohort 1: LG-0317 80 mg
Subjects will receive single dose of LG-0317 tablets.
Sponsors & Collaborators
-
LinGang Laboratory
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-24
- Primary Completion
- 2026-09-30
- Completion
- 2027-02-02
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