NCT05905120

Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)

A Single-Arm, Non-Randomized, Open-Label, Exploratory Mechanistic Validation (PoM) Clinical Trial of Toludivenlafaxine Hydrochloride Extended-Release Tablets Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain Using 11C-CFT Positron Emission Tomography (PET)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study was a single-arm, non-randomized, open-label clinical study to assess dopamine transporter occupancy in the brain of healthy adults using 11C-CFT positron emission tomography (PET)

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Toludivenlafaxine hydrochloride sustained-release tablets	80 mg/tablet, 2 tablets each time, once a day, for 4 days, orally at 30 min after the start of meals, 200 mL water to take

Timeline

• Start date: 2023-03-02
• Primary completion: 2023-06-30
• Completion: 2023-07-26
• First posted: 2023-06-15
• Last updated: 2023-07-27

Locations

1 site across 1 country: China