Idiopathic Pulmonary Fibrosis MedDRA version: 21.1 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: Capsule
INN or Proposed INN: C21
Current Sponsor code: C21
Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butylox
Sponsors
Vicore Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent obtained before the initiation of any trial related procedure 2) A diagnosis of IPF within 3 years prior to Visit 1 3) Age =40 years 4) FVC =80% predicted at Visit 1 5) FEV1/FVC ratio >0.7 prebronchodilator at Visit 1 6) Oxygen saturation (SpO2) >85% by pulse oximetry while breathing ambient air at rest at Visit 1 7) Diffuse capacity for carbon monoxide (DLCO) >30% of predicted normal corrected for haemoglobin at Visit 1 8) High-resolution computed tomography (HRCT) within 36 months prior to Visit 1 with central reading demonstrating: a. A pattern consistent with usual interstitial pneumonitis (UIP) b. Extent of fibrosis > extent of emphysema 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1)Previous and concomitant use of nintedanib or pirfenidone 2)Smoking (including e-cigarettes) within 6 months prior to Visit 1 3)Body mass index (BMI) >35 or 450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator oPositive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab oPositive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) 10)Inability to generate lung function data at Visit 1 meeting the minimum standards of the ATS/ERS 2005 guideline (Miller et al. 2005), as determined by central review 11)Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator 12)Pregnant or breast-feeding female subjects 13Female subjects of childbearing potential not willing to use contraceptive methods 14)Male subjects not willing to use contraceptive methods 15)Subjects not willing to adhere to dietary restrictions during the trial period 16)Participation in any other interventional trial during the trial period 17)Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety of C21 with 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF. ;Secondary Objective: To evaluate: •The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 24 weeks •The efficacy of C21 200 mg daily dose (100 mg b.i.d.) administered orally to subjects with IPF for 36 weeks •The pharmacokinetic (PK) profile of C21 200 mg daily dose (100 mg b.i.d.) after multiple dosing ;Primary end point(s): Nature and frequency of adverse events .;Timepoint(s) of evaluation of this end point: Occuring over the trial period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a)Change from baseline in forced vital capacity (FVC) value b)Plasma concentration of C21 and derived PK parameters evaluated in a sub-set of subjects ;Timepoint(s) of evaluation of this end point: for a) occurring over 12, 24, and 36 weeks | — |
Countries
Ukraine, United Kingdom
Contacts
Public ContactMimi Flensburg
Vicore Pharma AB
Outcome results
None listed