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

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: PIPE-307

• Registration Number: NCT04941781
• Lead Sponsor: Contineum Therapeutics

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-28
• Study Start: 2021-09-01
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10
• Status Verified: 2021-12
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

• Clinically relevant abnormal findings at the screening assessments
• Clinically relevant abnormal medical history or concurrent medical condition
• Acute or chronic illness
• Contraindications to MRI, CT, PET, or arterial cannulation procedures
• Significant exposure to research related radiation or other exposure (defined as ICRP category IIb or no more than 10 mSv)
• Positive tests for hepatitis B surface antigen (HBsAg) & Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody
• Drug or alcohol abuse
• Smoke more than 10 cigarettes daily
• Loss of more than 400 mL blood
• Vital signs or ECGs outside the acceptable range

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PIPE-307	PIPE-307	Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of \[11C\] PIPE- 307.

Primary Outcome Measures

Name	Time	Method
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours	24 hours

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom