PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Recep… (NCT04941781) | Clinical Trial Compass
CompletedPhase 1
PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
United Kingdom6 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours