EUCTR2021-006633-19-DK进行中（未招募）1 期
A Phase 2, Open-Label, Randomized, Safety, Pharmacokinetic, and Efficacy Study of Voriconazole Inhalation Powder Compared to Oral Voriconazole Tablets in Subjects with Acute Invasive Pulmonary Aspergillosis (IPA)
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
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects meeting the following inclusion criteria may be enrolled into the study:
- •1.Male or non-pregnant, non-lactating female aged 18 years or older at screening.
- •2.Diagnosed with acute proven or probable IPA prior to randomization
- •3.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and must agree to use highly effective contraceptive methods or abstinence from the time of screening for the duration of time on the study and continue to use acceptable contraceptive methods for 3 months after administration of the last dose of study treatment. Male subjects with female partners of childbearing potential must be congenitally sterile or surgically sterile (vasectomy with confirmation of aspermia) or agree to use 2 effective methods of contraception including 1 barrier method (e.g., condom with spermicide and contraception by female partner) for the duration of time on the study and for 3 months after administration of the last dose of study treatment.
- •4.Subject is considered clinically stable to participate in a 4-month study.
- •5.Capable of administering inhaled or oral drug product.
- •6.Subjects taking medications for treatment of other conditions that require or have recommended dose adjustment may be enrolled in the trial but must be willing to be carefully monitored and have medications managed in accordance with the VFEND summary of product characteristics
- •7.Continuous non-smoker or previous smoker who has not used nicotinecontaining products (including vaping) for at least 3 months prior to the first dosing and throughout the study, based on subject's self-reporting at Screening.
- •8.Body mass index (BMI) = 16.0 and = 32.0 kg/m2 at screening, and a minimum weight of at least 45.0 kg and a maximum weight of 120 kg at screening.
- •9.Succeeds in training on the use of the dry powder inhaler and is willing and able to perform adequate inhalation technique in the PI's (or designee's) opinion.
- •10.Able to generate an inspiratory flow rate of 60 L/minute using the In Check inspiratory peak flow meter or spirometry.
- •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 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Subjects meeting any of the following exclusion criteria must not be enrolled into the study:
- •1.Is legally incapacitated at the time of the screening visit or expected to be so during the conduct of the study in the opinion of the PI or designee.
- •2.History or presence of uncontrolled clinically significant medical condition or disease that, in the opinion of the PI or designee, would put the safety of the subject at risk, or that could affect the efficacy or safety analysis.
- •3.Evidence of disseminated systemic aspergillosis or any other systemic fungal diseases.
- •4.Presence of alcoholism or drug abuse or its history within the past 2 years prior to the first dosing.
- •5.History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or any triazole antifungal.
- •6.Has had surgery or any medical condition within 6 months prior to first dosing which may affect the absorption, distribution, metabolism, or excretion (ADME) of the study drug, in the opinion of the PI or designee.
- •7.Evidence of a mycetoma within the 12 months prior to screening.
- •8.Evidence of active systemic candidiasis upon screening or randomization.
- •9.Has active solid tumor cancer requiring chemotherapy and/or radiation therapy during the study. Hematological malignancies that have completed induction chemotherapy and are currently receiving consolidation therapy are allowed.
- •10.Current suspected or confirmed sepsis.
- •11.Positive results at screening for tuberculosis, human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus.
- •12.Subjects having an ECG with a prolonged QTcF (QT interval corrected according to Fridericia) greater than 450 msec for men and greater than
- •470 msec for women or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening.
- •13.Subjects are to be excluded if they are taking medications that are contraindicated in the VFEND summary of product characteristics.
- •14.Subjects with moderate or severe liver disease as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN) or a total bilirubin level > 3 times the ULN.
- •15.Subjects who have participated in another clinical study of an investigational drug or device medicine within 1 month before dosing, or
- •participation within 5 half-lives of receiving the last dose of an experimental drug (whichever is longer).
研究者
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