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

Launched by CONTINEUM THERAPEUTICS · Nov 8, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new study drug called PIPE-791, which may help treat two conditions: progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The main goal of the study is to see how much of the drug can reach the brain and lungs, as well as to check for any side effects and how the drug behaves in the body. Both healthy volunteers and those diagnosed with MS or IPF can participate.

To join the trial, participants need to be adults who can give informed consent and meet certain health criteria. Healthy volunteers must show no serious health issues, while those with MS or IPF need to have a confirmed diagnosis from a specialist. During the study, participants will take a single dose of the drug, provide samples of blood and urine, and undergo several PET scans, which are special imaging tests that help track the drug's effects. It's important for potential participants to be aware of certain restrictions, such as not being able to smoke or take other medications for a specified time before the study.

Gender

ALL

Eligibility 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