NCT04787302

PET Trial to Evaluate Target Occupancy of CVL-231 on Brain Receptors Following Oral Dosing

A Phase 1, Open-label Trial to Evaluate Target Occupancy of CVL-231 at Muscarinic Receptors Type 4 in Brain Following Single Oral Doses Using Positron Emission Tomography in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

PET Trial to Evaluate Target Occupancy of CVL-231 at Muscarinic Receptors Type 4 in Brain Following Oral Dosing

Detailed description

CVL-231 is a muscarinic acetylcholine receptor (mAChR) activator that selectively binds to the M4 muscarinic receptor subtype (M4 mAChR). CVL-231 is being developed for treatment of psychosis in schizophrenia. The aim of this trial is to characterize the relationship between the M4 receptor occupancy in different regions of the brain following a single oral doses of CVL-231 in healthy adult subjects by positron emission tomography (PET) using the radioligand \[11C\]MK-6884.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	CVL-231	Cohort 1: 30mg dose of CVL-231
DRUG	CVL-231	Cohort 2: CVL-231 dose to be decided based on results of Cohort 1 or trial may be concluded
DRUG	CVL-231	Cohort 3: CVL-231 dose to be decided based on results of Cohorts 1 and/or 2

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2021-03-08
• Last updated: 2023-07-27

Locations

2 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study