Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
研究概览
简要总结
This is a single dose, open label study in adult male subjects with cystic fibrosis to investigate the pharmacokinetics, safety and tolerability of GLPG2737.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject ≥18 years of age on the day of signing the informed consent form (ICF).
- •A confirmed clinical diagnosis of CF.
- •Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene belonging to class I and/or class II and/or class III (documented in the subject's medical record or CF registry).
- •Weight ≥40 kg.
- •Exocrine pancreatic insufficiency (documented in the subject's medical record).
- •Stable concomitant medication regimen for at least 2 weeks prior to study drug administration.
- •Forced expiratory volume in one second (FEV1) ≥40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator).
排除标准
- •History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
- •Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.
- •History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of splenomegaly, esophageal varices).
- •Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
研究组 & 干预措施
GLPG2737 single dose.
Single dose of GLPG2737 oral suspension.
干预措施: GLPG2737 single dose (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite.
时间窗: Between day 1 pre-dose and 48 hours post-dose.
To characterize the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h)
时间窗: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h)
时间窗: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Terminal plasma elimination rate constant (ke)
时间窗: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
Time of occurrence of Cmax for GLPG2737(tmax)
时间窗: Between day 1 pre-dose and 48 hours post-dose.
To determine PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Plasma concentration observed at 24 hours post-dos (C24h)
时间窗: Between day 1 pre-dose and 48 hours post-dose.
To assess PK parameters of GLPG2737 and its metabolite after given a single oral dose in CF subjects.
Apparent terminal elimination half-life ( t1/2)
时间窗: Between day 1 pre-dose and 48 hours post-dose.
To determine the PK of GLPG2737 and its metabolite after a single oral dose in CF subjects.
次要结局
- Number of subjects with adverse events.(Between screening and 15 days post-dose)