A Phase I Study to Explore the Pharmacokinetics of Clofazimine in Combination with Three Antimicrobial Drugs in Japanese Patients with Pulmonary MABC Disease (MYCAT)

未提供0 个研究点目标入组 10 人开始时间: 2022年8月9日最近更新: 2024年10月31日

试验速览

阶段: 不适用
状态: 进行中（未招募）
入组人数: 10
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 20age old over 至 85age old under（—）
性别: All

入选标准

•(Selection criteria to be confirmed at the time of obtaining consent)
•When obtaining consent, the investigator shall confirm the following 1) to 7) from the medical record, and confirm that the subject is able or willing to comply with 8) and 9).
•The subject has obtained written consent from the patient himself/herself to participate in this clinical trial.
•Japanese* patients with pulmonary MABC who meet the diagnostic criteria of the 2020 ATS/ERS/ESCMID/IDSA guideline.
•Japanese means the person/parents are Japanese nationals and the maternal and paternal grandparents are Japanese nationals.
•Patients whose age at the time of obtaining consent is between 20 and 85 years old
•Patients with clinical symptoms (sputum, cough, hemoptysis, chest pain, shortness of breath, fatigue, fever, night sweats, anorexia, weight loss, etc.) due to pulmonary MABC disease at the time of obtaining consent
•Patients with imaging findings (bronchiectasis, granular shadows, small nodular shadows, cavernous lesions, infiltrative shadows, etc. on chest CT) due to pulmonary MABCS. Imaging findings should be confirmed by imaging taken within 6 months prior to the start of screening.
•Must be able to take the study medication for the duration of the clinical trial.
•No history of antimicrobial agents with antimicrobial activity against pulmonary MABC disease within 4 weeks prior to the start of screening
•Patients who can be hospitalized for 16 days from the day before the start of treatment
•Female patients of childbearing potential who agree to use contraception during the study period and for at least 4 months after the last dose of clofazimine
•(Selection criteria to be confirmed during the screening period)
•Patients with at least one positive sputum culture or bronchoscopic specimen culture within 6 months prior to screening and with a positive culture specimen at screening. If the pre-screening positive is confirmed by sputum culture, the patient must have been positive at least twice, and one of those times must have been confirmed within 6 months prior to screening.

排除标准

•Patients with a history of oral administration of clofazimine
•Patients with a history of hypersensitivity to Lampren, clarithromycin, amikacin, or any component of imipenem hydrate or cilastatin sodium
•Patients receiving drugs contraindicated in the most recent clarithromycin package insert including pimozide, ergotamine tartrate/caffeine anhydrous, isopropylantipirine, suvorexant, lomitapide mesylate, tadalafil(adcirca), ticagrelor, ibrutinib, ibabradine hydrochloride, venetoclax (in the dose escalation phase of relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) during the dose-escalation phase), lurasidone hydrochloride, and anamorelin hydrochloride (contraindication to clarithromycin), etc.
•Patients with hepatic or renal impairment who are receiving colchicine (contraindication to clarithromycin)
•Patients with a history of hypersensitivity to aminoglycoside antibiotics or bacitracin (contraindication to amikacin)
•Patients with hearing loss or other hearing impairment due to aminoglycoside antibiotics in the patient or a blood relative (contraindication to Amikacin in principle)
•Patients receiving sodium valproate (contraindication to imipenem hydrate and cilastatin sodium)
•Patients at risk of the following QT interval prolongation
•(1) Patients with a history of torsade de pointe or other risk factors for heart failure
•(2) Patients with hypokalemia requiring clinical consideration of treatment
•(3) Patients with familial QT prolongation syndrome or a known family history of torsades de pointes
•(4) Patients with an average QTcF greater than 450 msec measured 3 times at 5 plus or minus 1 minute intervals on a 12-lead ECG performed at screening
•Patients receiving concomitant QT/QTc interval prolonging medications within 14 days prior to the start of treatment
•Patients whose laboratory values at screening conflict with the following
•(1) AST or ALT greater than or equal to 3 times the upper limit of the institutional reference value or total bilirubin greater than or equal to 2 times the upper limit of the institutional reference value
•(2) eGFR (mL/min/1.73 m2) less than 30 mL/min
•Patients with hearing loss or at risk of developing ototoxicity (deafness) due to concomitant medication (amikacin) [Patients should be referred to an otorhinolaryngologist if an abnormal hearing test (250-8000 Hz using air conduction) is detected during screening and an otorhinolaryngologist has confirmed that the patient has hearing loss or that the concomitant medication ( The patient should be excluded if an otolaryngologist determines that the patient has hearing loss or that ototoxicity (hearing loss) may occur with the use of concomitant medication (amikacin).
•Patients with respiratory depression due to neuromuscular weakness, etc., who are judged by the investigator to have problems participating in the study.
•Patients with a history of active primary, metastatic or other malignancy requiring treatment within 1 year prior to screening. (unless the malignancy is intraepithelial or has been cured by surgery or other treatment and the risk of recurrence is judged to be very low).
•Patients with positive HIV antibody, HCV antibody, HBs antigen, HBs antibody, or HBc antibody at screening (however, even if the HBs antibody or HBc antibody test is positive, the patient may be included only if the HBV-DNA is measured and negative at the physician's discretion.)
•Women with a positive pregnancy test or who are breastfeeding
•Patients with complications that affect absorption of oral intake (e.g., malabsorption syndrome) and whose absorption of the study drug and concomitant medications (oral drugs) is determined by the investigator to be affected.
•Patients who are currently abusing alcohol, drugs, or illegal drugs
•Patients who are otherwise judged by the investigator to have problems participating in the study.

结局指标

主要结局

PK/PD of clofazimine and clarithromycin, amikacin, imipenem hydrate and cilastatin sodium

次要结局

未报告次要终点

研究者

发起方

未提供

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