A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

MSD0 个研究点目标入组 40 人开始时间: 2012年9月28日最近更新: 2014年3月10日

适应症

试验速览

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•1.Each patient must be willing and able to provide, and give, written informed consent for the trial. 2.Each patient must be scheduled to undergo lung transplantation. 3.Each patient must be = 18 years of age and may be of either sex or any race/ethnicity. 4.Each patient must be able to adhere to dose and visit schedules. 5.Each patient must be able to take oral/nasogastric medication. 6. Patients undertake not to become pregnant during the study. Women of childbearing potential, male study participants and the sexual partners of men participating in this study must use an effective method of birth control while taking part in this study and for a period of six weeks after completion of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 39
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1.Hypersensitivity/previous reaction to posaconazole and related compounds, 2.Severe liver disease (Child –Pugh classification C), 3.Current use of ergot alkaloids or hydroxymethyl-coenzyme A (HMG-CoA) reductase inhibitors (simvastatin, lovastatin and atorvastatin) within 7 days prior to transplant. Pravastatin is permitted, 4.Current use of CYP3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days prior to transplant, 5.Treatment with posaconazole within 14 days prior to transplant, 6.The patient or a family member is among the investigational or sponsor staff directly involved with this trial.

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