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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pipeline Therapeutics, Inc.

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