NCT04941781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

October 5, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

June 18, 2021

Last Update Submit

October 4, 2022

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours

    24 hours

Study Arms (1)

PIPE-307

EXPERIMENTAL

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

Drug: PIPE-307

Interventions

PIPE-307DRUG

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.

PIPE-307

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 28, 2021

Study Start

September 1, 2021

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

October 5, 2022

Record last verified: 2021-12

Locations

GB(1)