Investigating PIPE-791 in healthy individuals and patients with progressive multiple sclerosis and idiopathic pulmonary fibrosis
A Phase 1b, Open-label Study of PIPE-791 to Determine Brain and Lung Lysophosphatidic Acid Receptor 1 (LPA1) Occupancy, by [18F] PIPE-497 PET Imaging in Healthy Volunteers, Volunteers With Progressive Multiple Sclerosis, and Volunteers With Idiopathic Pulmonary Fibrosis
This study is testing a new drug called PIPE-791 in healthy people and those with progressive multiple sclerosis or idiopathic pulmonary fibrosis to see how it works in the body and if it's safe.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Contineum Therapeutics Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (London) |
| Trial ID | NCT06683612 on ClinicalTrials.gov |
What this trial studies
This study evaluates PIPE-791, an investigational drug aimed at treating progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). Participants, including healthy volunteers and those diagnosed with PPMS or IPF, will receive a single dose of the drug and undergo multiple PET scans to assess how the drug distributes in the brain and lungs. Blood and urine samples will also be collected to monitor side effects and drug levels. The study aims to gather crucial data on the pharmacokinetics and safety of PIPE-791.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers, individuals with primary progressive multiple sclerosis, or those diagnosed with idiopathic pulmonary fibrosis.
Not a fit: Patients with severe adverse reactions to drugs, active infections like hepatitis or HIV, or those with a history of drug or alcohol abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for patients with progressive multiple sclerosis and idiopathic pulmonary fibrosis.
How similar studies have performed: While this approach is novel, similar studies targeting drug distribution in the brain and lungs have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Main Inclusion Criteria * All parts: male volunteers or female volunteers of non-childbearing potential; agree to follow the contraception requirements of the trial, and able to give fully informed written consent. * Part A: normotensive volunteers, deemed healthy on the basis of a clinical history, medical examinations, ECG, vital signs, and laboratory tests of blood and urine. * Part B: volunteers with a diagnosis of PPMS or SPMS by a neurologist, according to the 2017 Revised McDonald Criteria. * Part C: volunteers with a diagnosis of IPF by a pulmonologist, according to the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline, within 7 years before screening. Main Exclusion Criteria * Positive tests for hepatitis B and C, human immunodeficiency virus (HIV) * Severe adverse reaction to any drug; sensitivity to trial medication * Drug or alcohol abuse * Smoking or use of tobacco or nicotine-containing products from 7 days before screening, until the final visit * Use of a prescription medicine (except hormone replacement therapy \[HRT\] in women, and medications for participants with PrMS and IPF at the discretion of the investigator), or any substance known to interact with cytochrome p450 (CYP)3A enzymes (including St. John's wort and foodstuffs such as grapefruit juice) during the 28 days before the first dose of PIPE-791 * Use of any other over-the-counter medicine, with the exception of acetaminophen (paracetamol) during the 7 days before the first dose of PIPE-791, or received vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), during the 7 days before screening * Participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the 3 months before the baseline PET scan * Vital signs or ECGs outside the acceptable range at screening * Clinically relevant abnormal findings at the screening assessments, including C-SSRS and MRI (Parts A \[brain PET imaging arm\] and B only) * Acute or chronic illness (except PrMS and IPF in Parts B and C, respectively) * Clinically relevant abnormal medical history or concurrent medical condition * Possibility that volunteer will not cooperate * Contraindications to MRI (Parts A \[brain PET imaging arm\] and B only), computed tomography (CT), PET, or arterial cannulation procedures * Significant exposure to research-related radiation or other radiation exposure (exceeding 10 mSv when added to exposure from this study) within the previous 12 months
Where this trial is running
London
- Hammersmith Medicines Research — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.