Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation 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
- Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
研究概览
简要总结
This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.
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 ICF.
- •A confirmed clinical diagnosis of CF.
- •Exocrine pancreatic insufficiency (documented in the subject's medical record).
- •Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration
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.
- •Need for supplemental oxygen during the day, and >2 L/minute while sleeping.
- •History of solid organ or hematopoietic cell transplantation.
- •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.
- •Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.
研究组 & 干预措施
GLPG3067 single dose.
Single Dose of GLPG3067 film coated tablets.
干预措施: GLPG3067 single dose (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
时间窗: Between Day 1 pre-dose and Day 4.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Maximum observed plasma concentration (cmax) of GLPG3067 single dose.
时间窗: Between Day 1 pre-dose and Day 4.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
时间窗: Between Day 1 pre-dose and Day 4.
To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
次要结局
- The number of subjects with adverse events.(From screening to 19 days after the last dose.)