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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04941781
Recruitment Status : Completed
First Posted : June 28, 2021
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Pipeline Therapeutics, Inc.

Study Description
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04941781


Locations
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United Kingdom
Hammersmith Medicines Research
London, United Kingdom
Sponsors and Collaborators
Pipeline Therapeutics, Inc.
More Information
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Responsible Party: Pipeline Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04941781    
Other Study ID Numbers: PTI-307-102
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pipeline Therapeutics, Inc.:
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases