Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease

Exclusion Criteria

• •Subject with a current diagnosis of ulcerative colitis (UC);
• •Contraindication to the use of itraconazole including congestive heart failure, ventricular dysfunction, ventricular arrhythmia, or negative inotropic state;
• •Subjects with elevated or abnormal liver enzymes (ALT/AST\>3 ULN) or patients with pre-existing chronic or active liver disease at screening;
• •Female subject who is pregnant, planning to become pregnant during the study, or breastfeeding;
• •Subject with renal impairment (creatinine clearance ≤ 50 mL/min using Cockcroft-Gault equation);
• •Subject with a known hypersensitivity to itraconazole, terbinafine, or any of their excipients;
• •Subjects on medications which interact with itraconazole: methadone, pimozide, quinidine or other CYP3A4 inhibitors;
• •Positive C. difficile toxin test at screening;
• •Use of steroid greater than 20 mg/day;
• •Change of steroid dosage in the 2 weeks prior to enrolment;
• •Change in CD therapy:
• •* The Anti-TNFs, anti-integrins, anti-IL12/23 in the 4 months prior to enrolment;
• •* Thiopurines or methotrexate (MTX), in the 2 months prior to enrolment;
• •Participation in other clinical trial within 30 days of signing the Information and Consent Form (ICF).