A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327

Study Overview
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Brief Summary
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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).

Official Title
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An Open-Label Study to Evaluate the Safety, Tolerability, Kinetics, and Repeatability of the Novel Lysophosphatidic Acid Receptor 1 (LPA1) Positron Emission Tomography (PET) Ligand 18F-BMS-986327

Conditions
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Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)

Intervention / Treatment
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* Diagnostic Test: 18F-BMS-986327


Participation Criteria
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Eligibility Criteria
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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: Male and female healthy volunteers ages 18 or age or older No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory determinations Idiopathic Pulmonary Fibrosis (IPF) Participants: Male and female participants aged 40 to 90 years Diagnosis of IPF less than 6 years before randomization Have no features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage or surgical lung biopsy Exclusion Criteria (all participants): Severe motor problems that prevent the ability to lie still for PET imaging procedure Significant acute or chronic medical illness in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of 18F-BMS-986327 Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug Any major surgery within 4 weeks of study drug administration Other protocol-defined criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Diagnostic Test: 18F-BMS-986327<br>* Imaging Agent<br>|
| Experimental: Part 2<br> | Diagnostic Test: 18F-BMS-986327<br>* Imaging Agent<br>|
| Experimental: Part 3<br> | Diagnostic Test: 18F-BMS-986327<br>* Imaging Agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)