NCT02824666

Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242

Phase 1, Open-Label Positron Emission Tomography (PET) Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242 in Adult Male Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Braeburn Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using \[18F\] Fallypride PET in up to three cohorts of subjects.

Detailed description

This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using \[18F\]Fallypride PET in up to three cohorts of subjects. The first dose evaluated will be 0.5 mg/kg administered as an IV bolus injection. The second dose that will be evaluated will be 1.0 mg/kg as an IV bolus injection. The safety and occupancy after each dose level will be evaluated prior to moving to the next dose. On two separate days, subjects will undergo \[18F\]Fallypride PET imaging sessions. The plasma concentration of ATI-9242 will be obtained prior to and during the course of the imaging session to allow determination of the relationship between plasma concentration of ATI-9242 with in vivo D2 occupancy.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	ATI-9242	Formulated ATI-9242 will be administered as an IV bolus injection (2mg/mL of ATI-9242 in 40% solution of propylene glycol). Two doses will be tested: single IV bolus injection of 0.5mg/kg and single IV bolus injection 1.0 mg/kg. In the event that a third cohort is needed the IV bolus injection would be 2.0 mg/kg
RADIATION	[18F]Fallypride Imaging	Subjects will be injected with approximately 250 MBq or 6.75 mCi of \[18F\]Fallypride \[5-6 mCi being the typical range of injected dose\].

Timeline

• Start date: 2016-06-20
• Primary completion: 2016-09-06
• Completion: 2016-11-08
• First posted: 2016-07-07
• Last updated: 2017-07-17

Locations

1 site across 1 country: United States