PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF

Phase 1

Not yet recruiting

• Conditions: Idiopathic Pulmonary Fibrosis (IPF); Idiopathic Pulmonary Fibrosis; Multiple Sclerosis; Multiple Sclerosis, MS; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Progressive; Multiple Sclerosis, Secondary Progressive; Healthy; Healthy Volunteers
• Interventions: Drug: PIPE-791

• Registration Number: NCT06683612
• Lead Sponsor: Contineum Therapeutics

Brief Summary

This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy volunteers and patients.

Participants will:

* Take a single dose of the study drug

* Give many samples of blood and urine

* Have multiple PET scans

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-08
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers, brain PET imaging	PIPE-791	-
Healthy volunteers, lung PET imaging	PIPE-791	-
Volunteers with PrMS	PIPE-791	-
Volunteers with IPF	PIPE-791	-

Primary Outcome Measures

Name	Time	Method
LPA1 occupancy as determined by regional total volume of distribution (VT) at each brain scan.	Baseline to up to 28 days post-dose
LPA1 occupancy as determined by regional total volume of distribution (VT) at each lung scan.	Baseline to up to 28 days post-dose

Secondary Outcome Measures

Name	Time	Method
The relationship between PIPE-791 plasma concentration and brain and lung LPA1 occupancy.	Baseline to up to 28 days post-dose
The PIPE-791 EC50 (i.e., the plasma concentration of PIPE-791 associated with 50% occupancy of LPA1) in the brain and lungs.	Baseline to up to 28 days post-dose
Pharmacokinetics (PK): blood concentration levels of PIPE-791	Baseline to up to 28 days post-dose
Safety and tolerability: Treatment-Emergent Adverse Events (TEAE)	Baseline to up to 32 days post-dose

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom