Open-label PET study in healthy male participants to characterise RO MIJ821 in the brain
Research type
Research Study
Full title
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
IRAS ID
1006381
Contact name
Saptha Korapati
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-002317-42
Research summary
This is a phase I, open label, adaptive design trial in up to 10 healthy male participants (23 - 55 years) at a single centre.
The main purpose is to evaluate the relationship between the amount of MIJ821 in the blood and the amount of bound MIJ821-target protein in the brain after one injection of MIJ821 into a vein. This evaluation will be performed using an imaging test that uses radiation and measures activity of cells in body tissues (positron-emission tomography, PET). For this, a small amount of a radioactive substance (radiotracer) binding the same target as MIJ821 is injected to measure reduction of tracer-binding in the brain due to competition with MIJ821.
The results will help to identify clinically relevant MIJ821 doses for future trials. It will also be investigated how the trial medicine is taken up, chemically broken down, distributed, and removed from the body and the safety of MIJ821 will be evaluated.
The trial consists of a screening period of up to 45 days, a treatment and follow up period (in house) of 4 days, a follow-up visit on Day 9 and a safety phone call 30 days after dosing.
Each participant will have a PET scan before Day 1, receive a single dose of MIJ821 on Day 1 followed by 2 PET scans on the same day. The participants will be divided into 5 groups of 2 participants each. In the first group 0.048 mg/kg MIJ821 will be given over 40 minutes, in the following groups, the dose will be modified within the range of 0.016 - 0.32 mg/kg.MIJ821 is being developed by Novartis for the treatment of severe depression. MIJ821 has not been approved by health authorities for the treatment of patients. Three clinical studies with MIJ821 have been completed and 5 are ongoing.
REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0671
Date of REC Opinion
21 Dec 2022
REC opinion
Further Information Favourable Opinion