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

Contineum Therapeutics

Status and phase

Completed

Phase 1

Conditions

Multiple Sclerosis

Treatments

Drug: PIPE-307

Study type

Interventional

Funder types

Industry

Identifiers

NCT04941781

PTI-307-102

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Criteria:

Normotensive male or female volunteers between 25-65 years old
Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine

Key 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