EUCTR2015-004157-41-GB进行中（未招募）1 期
Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Galapagos NV
- 入组人数
- 23
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
- •1. Subjects who are able and willing to sign the ICF as approved by the independent ethics committee (IEC).
- •2. Male or female subjects of non-child-bearing potential aged = 40 years on the day of signing the ICF.
- •Note: Female subjects will be considered of non-childbearing potential if they are either sterilized, ovariectomized, hysterectomized, or postmenopausal (i.e., at least 24 months of amenorrhea in the absence of other biological or physiological causes [in case of doubt, the subject’s follicle stimulating hormone [FSH] levels will be determined and the subject will be considered postmenopausal if the FSH level is = 35 mIU/mL).
- •3. Subjects with a chest HRCT performed within 12 months prior to Screening visit.
- •4. Subjects with IPF diagnosed by a multidisciplinary team and confirmed by central review of the subject’s HRCT pattern and SLB (if available)
- •5. Subjects meeting all of the following criteria:
- •a. FVC =50% predicted of normal
- •b. Diffusing capacity for the lungs for carbon monoxide (DLCO) = 30% predicted of normal (corrected for hemoglobin) (see Appendix 3 for additional details)
- •6. Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli index) ratio = 0.70 (based on pre-bronchodilator spirometry).
- •7. Subjects who are on stable supportive care (e.g., supplemental oxygen, pulmonary rehabilitation) for at least 3 weeks prior to screening and during screening period.
- •8. Subjects must be in a stable condition and acceptable for study participation based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation.
- •9. Subjects must have an estimated minimum life expectancy of 12 months in the opinion of the investigator.
- •10. Male subjects and their female partners must use a highly effective method of birth control.
- •11. Subjects who are able to understand the importance of adherence to study treatment, study procedures and requirements, including the concomitant medication restrictions.
- •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 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Subjects with a known hypersensitivity to any of the study drug ingredients or a history of a significant allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization).
- •2. Subjects with a history of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection).
- •3. Subjects with a history of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, and prostate cancer medically managed through active surveillance or watchful waiting).
- •4. Subjects with clinically significant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QT interval corrected for heart rate using Fridericia’s formula [QTcF] =450 ms, or a known long QT syndrome).
- •Note: A first degree heart block will not be considered as a significant abnormality.
- •5. Subjects with acute IPF exacerbation within 6 weeks prior to screening and during the screening period.
- •6. Subject with a lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and during the screening period.
- •7. Subjects who have been smoking within 3 months prior to screening.
- •8. Interstitial lung disease (ILD) associated with known primary diseases (e.g., sarcoidosis, amyloidosis, etc.), exposures (e.g., radiation, silica, asbestos, coal dust, etc.), and drugs (e.g., amiodarone, etc.).
- •9. Subjects with a history of lung volume reduction surgery or lung transplant.
- •10. Subjects with an unstable cardiac or pulmonary disease (other than IPF) within 6 months prior to screening or during the screening period, including but not limited to:
- •a. unstable angina pectoris, myocardial infarction
- •b. congestive heart failure requiring hospitalization
- •11. Subjects with any clinical condition or circumstance that in the opinion of the investigator may make a subject unsuitable for inclusion or unable to complete the study or comply with study procedures and requirements.
- •12. Subjects with a contra-indication for bronchoscopy and bronchoalveolar lavage in the opinion of the investigator.
- •13. Subjects with an abnormal liver function defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin >3 x upper limit of the normal range (ULN).
- •14. Subjects with an abnormal renal function defined as creatinine clearance < 50 mL/min using the Cockroft-Gault equation.
- •15. Subjects participating in a drug/device or biologic investigational research study (concurrently with the current study or within 8 weeks prior to screening).
- •16. Subjects using of any of the following therapies within 4 weeks before screening:
- •a. Pirfenidone
- •b. Nintedanib
- •c. Warfarin
- •d. Imatinib
- •e. Ambrisentan
- •f. Azathioprine
- •g. Cyclophosphamide
- •h. Cyclosporine A
- •i. Prednisone at steady dose > 15 mg/day (for details, see Section 4.2.4)
- •j. Any experimental IPF therapy
- •17. Subjects with active alcoh
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