A Phase 1, Open-label Study of PIPE-307 to Determine Muscarinic Type I Receptor (M1AChR) Occupancy Parameters by [11C] PIPE-307 PET Imaging in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Contineum Therapeutics
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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
Arms & Interventions
PIPE-307
Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of [11C] PIPE- 307.
Intervention: PIPE-307 (Drug)
Outcomes
Primary Outcomes
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
Time Frame: 24 hours
Secondary Outcomes
No secondary outcomes reported