Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)
Conditions
Keywords
Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)
Brief summary
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).
Interventions
DIAGNOSTIC_TEST18F-BMS-986327
Imaging Agent
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed