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

Treatment tested

• PIPE-307

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

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.