EUCTR2017-004923-63-GB进行中（未招募）1 期
A phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients will be entered into this study only if they meet all of the following criteria:
- •1. Written informed consent consistent with ICH-GCP and local laws signed prior to entry into the study.
- •2. Male patient or female patient of non-childbearing potential with IPF (for definition of woman of childbearing potential [WOCBP], refer to protocol section 6.1.1.8.).
- •3. Patients >60 years of age.
- •4. Patients with a FVC =45% predicted and an FEV1/FVC ratio =0.7 before bronchodilator.
- •5. Patients with oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest.
- •6. Patients with a diagnosis consistent with IPF prior to screening based on ATS/ERS/JRS/ALAT (American, European, Japanese and Latin American Respiratory Societies) consensus criteria.
- •7. Patients with a diffusing capacity (DLCO - transfer factor of the lung for carbon monoxide) >20%.
- •8. Patients with longitudinal factors in past 12 months associated with an increased risk of mortality related to IPF according to ATS/ERS/JRS/ALAT consensus criteria: either a documented increased level of dyspnea, a decrease in FVC by =10% absolute value, a decrease in DLCO by =15% absolute value, a worsening of fibrosis on high resolution computed tomography (HRCT) confirmed in the radiologist report.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Patients will be entered into this study only if they meet none of the following criteria:
- •1. Concomitant use of angiotensin receptor blockers (ARBs).
- •2. Concomitant or previous (2 months) use of nintedanib or pirfenidone.
- •3. Current smoker.
- •4. HRCT pattern showing emphysema more than the extent of fibrosis of the lung area, conducted within 12 months of Day 1.
- •5. Use of systemic immunosuppressants within 30 days of Day 1.
- •6. Patients currently receiving oral corticosteroids, cytotoxic drugs (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapies for pulmonary hypertension (e.g., bosentan), unapproved (e.g., interferon-?, penicillamine, cyclosporine, mycophenolate) and/or investigational therapies for IPF or administration of such therapies within 4 weeks of initial screening.
- •7. Patients treated with strong inhibitors and inducers of CYP3A4 either during the study or 14 days prior to enrolment in the study: antifungals (e.g., ketoconazole, itraconazole), clarithromycin, telithromycin, cobicistat, protease inhibitors (e.g., atazanavir, ritonavir, and saquinavir) and grapefruit juice, phenytoin, carbamazepine, barbiturates, rifampin and St. John's Wort).
- •8. Long QT syndrome (LQTS).
- •- A marked baseline prolongation of QT/QTc interval (demonstration of a QTc interval >450 milliseconds)
- •- A history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of LQTS)
- •- Use of concomitant medications that prolong the QT/QTc interval.
- •9. PR-interval >0.2 seconds or any AV block or QTc intervals >500 msec, calculated with Bazett’s method of correction [QTc=QT/RR E^1/2].
- •10. Patients newly prescribed (<3 months at screening) glycosides, beta-blockers, calcium channel blockers, and cholinesterase inhibitors.
- •11. Documented orthostatic hypotension as well as patients with a diastolic blood pressure less than 60 mmHg and a systolic blood pressure less than 110 mmHg.
- •12. History of (or current) asthma requiring daily maintenance treatment.
- •13. Participation in a clinical study of an unlicensed drug in the previous 4 months, or a marketed drug study within the previous 3 months.
- •14. At baseline/screening visit, values of liver transaminases above 3 times upper limit, alkaline phosphatase above 2.5 times upper limit, or bilirubin above 1.5 times upper limit.
- •15. Creatinine clearance (CrCl) <60 ml/min (determined by Cockcroft-Gault Equation) at baseline/screening visit.
- •16. Abnormality of cornea (other than scars, congenital abnormality or corneal tearfilm insufficiency).
- •17. Currently receiving drugs with known corneal toxicity (e.g., hydroxychloroquine, amiodarone, tamoxifen, and chlorpromazine).
- •18. History of dry-eye syndrome (e.g., Sjogren’s syndrome).
- •19. History of ocular surface abnormality (including Stevens–Johnson syndrome and alkali burns).
- •20. Eyes within a previous radiotherapy field.
- •21. Current use of contact lenses (previous contact lens wearers are eligible if their eye examination is within normal limits).
- •22. Contrain
研究者
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