Back to resultsPET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
PIPE-307
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis
Eligibility 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
Sites / Locations
- Hammersmith Medicines Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PIPE-307
Arm Description
Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of [11C] PIPE- 307.
Outcomes
Primary Outcome Measures
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
Secondary Outcome Measures
Full Information
NCT ID
NCT04941781
First Posted
June 18, 2021
Last Updated
October 4, 2022
Sponsor
Pipeline Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04941781
Brief Title
PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pipeline Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PIPE-307
Arm Type
Experimental
Arm Description
Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of [11C] PIPE- 307.
Intervention Type
Drug
Intervention Name(s)
PIPE-307
Intervention Description
Each dose cohort will receive a single oral dose of PIPE-307. Doses to be tested in subsequent cohorts will be determined by the analysis of the exposure from PK data and the PET scans with [11C] PIPE-307.
Subjects will receive an intravenous dose of the radioligand [11C] PIPE-307 prior to PET imaging.
Primary Outcome Measure Information:
Title
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
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