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 range25 Years – 65 Years
SexALL
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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
What they're measuring
1
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours