跳至主要内容
临床试验/NCT04069143
NCT04069143已完成1 期

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

Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年10月1日最近更新:
适应症

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

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

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

A Study to Evaluate the Safety, Tolerability,... | 临床试验