NCT04941781

PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers

A Phase 1, Open-label Study of PIPE-307 to Determine Muscarinic Type I Receptor (M1AChR) Occupancy Parameters by [11C] PIPE-307 PET Imaging in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Contineum Therapeutics · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, open-label, adaptive-design PET study to investigate the occupancy of brain muscarinic Type 1 receptors (M1AChR) by PIPE-307 in healthy volunteers.

Detailed description

This is a Phase 1, single-center, open-label, adaptive-design study to investigate the occupancy of brain M1AChR after a single oral dose of PIPE-307 in healthy volunteers by positron emission tomography (PET) using the radioligand \[11C\] PIPE-307. This study will have an adaptive design to adequately evaluate the relationship between PIPE-307 exposure and brain M1AChR occupancy.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	PIPE-307	Each dose cohort will receive a single oral dose of PIPE-307. Doses to be tested in subsequent cohorts will be determined by the analysis of the exposure from PK data and the PET scans with \[11C\] PIPE-307. Subjects will receive an intravenous dose of the radioligand \[11C\] PIPE-307 prior to PET imaging.

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2021-06-28
• Last updated: 2022-10-05

Locations

1 site across 1 country: United Kingdom