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

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

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: PIPE-307 Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : November 10, 2021
Actual Study Completion Date : November 10, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: PIPE-307
Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of [11C] PIPE- 307.
 Drug: PIPE-307

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.
Outcome Measures
Primary Outcome Measures :
  1. M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
United Kingdom
Hammersmith Medicines Research
London, United Kingdom
Sponsors and Collaborators
Pipeline Therapeutics, Inc.
Tracking Information
First Submitted Date  ICMJE June 18, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date December 2, 2021
Actual Study Start Date  ICMJE September 1, 2021
Actual Primary Completion Date November 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2021) 		M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021) 		To determine the brain M1AChR occupancy using [11C] PIPE-307 PET imaging, following a single oral dose of PIPE-307 [ Time Frame: Baseline up to 48 hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: PIPE-307

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.
Study Arms  ICMJE Experimental: PIPE-307
Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of [11C] PIPE- 307.
Intervention: Drug: PIPE-307
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2021) 		6
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2021) 		8
Actual Study Completion Date  ICMJE November 10, 2021
Actual Primary Completion Date November 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04941781
Other Study ID Numbers  ICMJE PTI-307-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pipeline Therapeutics, Inc.
Study Sponsor  ICMJE Pipeline Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pipeline Therapeutics, Inc.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP