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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941781
• Other study ID #: PTI-307-102
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: November 10, 2021

Study information

• Verified date: December 2021
• Source: Pipeline Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Pipeline Therapeutics, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours		24 hours