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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers, brain PET imaging | Experimental |
| |
| Healthy volunteers, lung PET imaging | Experimental |
| |
| Volunteers with PrMS | Experimental |
| |
| Volunteers with IPF | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPE-791 | Drug | Subjects will receive a single oral dose of PIPE-791. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Main Inclusion Criteria
Main Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Huhn, MD | Contineum Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | United Kingdom |
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| 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 |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D009103 | Multiple Sclerosis |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D000090862 | Neuroinflammatory Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D010335 | Pathologic Processes |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D007154 | Immune System Diseases |
| D012598 | Sclerosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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