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

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.

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