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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Test-retest repeatability
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Test-retest repeatability
时间窗: 30 days after participant's participation
Biodistribution and lung uptake calculated from PET-CT images in participants with IPF
时间窗: 30 days after participant's participation
Incidence of adverse events (AEs)
时间窗: Up to 3 days after participant's participation
Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images
时间窗: 30 days after participant's participation
Incidence of serious adverse events (SAEs)
时间窗: Up to 30 days after participant's participation
次要结局
未报告次要终点