NCT05666687

An Open-label, Adaptive Design, Positron Emission Tomography Study in Healthy Male Participants to Characterize Receptor Occupancy by MIJ821 in the Brain

An Open-label, Adaptive Design Study in Healthy Male Participants to Characterize the Occupancy of NR2B Subunit Containing NMDA Receptors in the Brain Following a Single Intravenous Dose of MIJ821 Using Positron Emission Tomography (PET) With the Radioligand [11C]Me-NB1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to confirm binding of MIJ821 to the NR2B-containing NMDA receptors in the human brain and assess the PC-RO relationship over time using positron emission tomography (PET).

Detailed description

This is a Phase I, open-label, adaptive design study in healthy male participants using PET imaging with the radioligand \[11C\]Me-NB1 to measure occupancy of the NR2B-containing NMDA receptors by MIJ821. This exploratory study will be performed at a single clinical site and a separate PET imaging site. Up to 10 participants will be enrolled into 5 sequential cohorts. Each participant will receive a single dose of MIJ821 as an i.v. infusion. As part of the adaptive design, the dose of MIJ821 will be changed across cohorts to achieve the primary study objective in the smallest possible number of participants. After confirming eligibility during screening, each participant will undergo a baseline PET scan. Each participant will receive a single dose of i.v. MIJ821 during the treatment period, followed by up to two post dose PET scans. Post dose safety assessments will be performed up to End of Study visit which will happen once between Day 9 and Day 15.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	MIJ821	MIJ821 will be administered as an i.v. infusion

Timeline

• Start date: 2023-01-11
• Primary completion: 2023-11-07
• Completion: 2023-11-07
• First posted: 2022-12-28
• Last updated: 2024-04-01

Locations

1 site across 1 country: United Kingdom