Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 20.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: C21
Pharmaceutical Form: Oral solution in single-dose container
INN or Proposed INN: PD00377 Na-salt
Other descriptive name: COMPOUND 21
Sponsors
Vicore Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Withdrawn consent of the patient;Timepoint(s) of evaluation of this end point: From Screening Period (Day -28) to the end of Follow Up-Period (Day 57+2) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of C21 in patients with IPF.; Primary end point(s): Incidence of Adverse Events (AEs) reported by the subject or observed by the Investigator ; Secondary Objective: Secondary objectives are evaluation of: • Biomarkers (C1M, C3M, PRO-C3). • Lung function. • Pharmacokinetics of C21 in IPF patients. Exploratory objectives are evaluation of: • Exploratory biomarkers related to IPF. ; Timepoint(s) of evaluation of this end point: From Screening Period (Day -28) to the end of Follow Up-Period (Day 57+2) | — |
Countries
Bulgaria, Poland, Serbia, United Kingdom
Contacts
Public ContactKicki Johansson
Vicore Pharma AB
Outcome results
None listed