EUCTR2016-001440-18-NL进行中（未招募）1 期
Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy controls
- •-Males and females, aged 18 years or older on the date of informed consent
- •-No medical history
- •-Signed informed consent form (ICF)
- •Cystic fibrosis patients
- •-Males and females, aged 18 years or older on the date of informed consent
- •-Cystic fibrosis (confirmed by genotype analysis, Class 1 and 2)
- •-Exocrine pancreatic insufficiency
- •-Signed informed consent form (ICF)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Use of ivacaftor
- •-Hepatic impairment defined as (a history of) transaminase elevations
- •-Severe renal impairment (creatinine clearance = 30 ml/min);
- •-Use of drugs that are metabolized by the CYP3A enzyme or have a known influence on the CYP3A enzyme (inducers or inhibitors): see appendix.
- •-Known allergy/intolerance to clarithromycin, ritonavir or azithromycin
- •-Pregnancy or lactation
- •-Pregnancy wish
- •-Pulmonary exacerbation with hospital admission within one month before the study period (defined as need for intravenous antibiotics)
研究者
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