Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI

HagaZiekenhuis0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年2月28日

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•Inclusion criteria for Healthy controls
•-Males and females, aged 18 years or older on the date of informed consent
•-No medical history and no medication
•-Signed informed consent form (ICF)
•- Able to understand and comply with protocol requirements, restrictions, and instructions, and likely to complete the study as planned, as judged by the investigator.;Inclusion criteria for 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)
•- Able to understand and comply with protocol requirements, restrictions, and instructions, and likely to complete the study as planned, as judged by the investigator

•For both healthy controls as CF-patients the following exclusion criteria apply:
•- Use of ivacaftor
•- History of clinically significant cirrhosis with or without portal hypertension.
•- 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) ;For the Healthy controls an extra Exclusion Criterium applies:
•- Blood relationship in the first or second degree with a CF-patient

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