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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-11-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PIPE-307

Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of \[11C\] PIPE- 307.

Group Type EXPERIMENTAL

PIPE-307

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes