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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Test-retest repeatability
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Test-retest repeatability
Time Frame: 30 days after participant's participation
Biodistribution and lung uptake calculated from PET-CT images in participants with IPF
Time Frame: 30 days after participant's participation
Incidence of adverse events (AEs)
Time Frame: Up to 3 days after participant's participation
Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images
Time Frame: 30 days after participant's participation
Incidence of serious adverse events (SAEs)
Time Frame: Up to 30 days after participant's participation
Secondary Outcomes
No secondary outcomes reported