Assessment of cytochrome P450 function in patients with severe COPD using a phenotyping drug cocktail

Dr Richard McNeill0 个研究点目标入组 24 人开始时间: 2019年6月18日最近更新: 2019年7月15日

适应症

试验速览

暂无简介。

•Healthy volunteers:
•Age over 18 years old
•Ability to understand and the willingness to sign or verbally consent to a written or verbal informed consent document
•Ability to abstain from caffeine for 48 hours prior to the study and for the duration of the pharmacokinetic sampling
•Body mass index 18 – 30
•Patients with COPD:
•COPD with GOLD D severity
•Body mass index less than or equal to 25
•Age over 18 years old
•Ability to understand and the willingness to sign or verbally consent to a written or verbal informed consent document
•Ability to abstain from caffeine for 48 hours prior to the study and for the duration of the pharmacokinetic sampling
•Ability to safely swallow tablets

•Healthy volunteers:
•Known sensitivity or contraindications to any of the cocktail drugs
•Concomitant use of any of the study medicines (except caffeine)
•Concomitant use of medicines known to be moderate or major inhibitors or inducers of cytochrome P450
•Current smoker
•Any medical condition expected to affect study drug metabolism or ability to participate in the study
•Patients with COPD:
•Known sensitivity or contraindications to any of the cocktail drugs
•Concomitant use of any of the study medicines (except caffeine)
•Concomitant use of medicines known to be moderate or major inhibitors or inducers of cytochrome P450
•Current smoker
•Liver cirrhosis
•Active hepatitis
•Significant small bowel resection
•Oral corticosteroid use in the last 2 weeks
•Exacerbation of COPD in the last 2 weeks
•Intercurrent illness expected to affect study drug metabolism
•Using domiciliary oxygen
•Active malignancy

发起方

Dr Richard McNeill