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The purpose of this study is to assess the safety, tolerability, kinetics and test-retest repeatability of the novel LPA1 positron emission tomography (PET) ligand 18F-BMS-986327 in healthy participants and participants with idiopathic pulmonary fibrosis (IPF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
| |
| Part 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-BMS-986327 | Diagnostic Test | Imaging Agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 3 days after participant's participation | |
| Incidence of serious adverse events (SAEs) | Up to 30 days after participant's participation | |
| Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images | 30 days after participant's participation | |
| Test-retest repeatability | 30 days after participant's participation | |
| Biodistribution and lung uptake calculated from PET-CT images in participants with IPF | 30 days after participant's participation |
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Inclusion Criteria:
All Participants:
· Body mass index of 18.0 to 34.0 kg/m^2, inclusive, and body weight ≥ 50 kg
Healthy Participants:
Idiopathic Pulmonary Fibrosis (IPF) Participants:
Exclusion Criteria (all participants):
Other protocol-defined criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | New Haven | Connecticut | 06520-8048 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| FDA Safety Alerts and Recalls | View source |