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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	25 Years - 65 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06683612
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Contineum Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stephen Huhn, MD
Principal Investigator Affiliation	Contineum Therapeutics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Arms & Interventions

Arms

Experimental: Healthy volunteers, brain PET imaging

Experimental: Healthy volunteers, lung PET imaging

Experimental: Volunteers with PrMS

Experimental: Volunteers with IPF

Interventions

Drug: - PIPE-791

Subjects will receive a single oral dose of PIPE-791.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.