Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)

Exclusion Criteria

• •1. Participation to another clinical trial where investigational drug was received, and last investigations were performed less than 8 weeks prior to screening;
• •2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders, gastric surgery recent or in the past, and/or impaired gastric motility
• •3. Clinically relevant abnormal laboratory values
• •4. Abnormal liver enzymes at screening
• •5. Subjects with history of breathing problems
• •6. Positive HIV1 or HIV2 serology
• •7. Positive results from the Hepatitis serology
• •8. Blood donation or blood loss (equal or more than 450 ml) less than 2 months prior to screening or before the first dosing;
• •9. Positive urine test for cotinine
• •10. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test
• •11. Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen
• •12. Intake of non-permitted concomitant medications in the predefined period
• •13. Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or before the first dosing;
• •14. Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;
• •15. Known allergy to antifungal medicines;
• •16. Unsuitable veins for repeated venipuncture;
• •17. Heavy caffeine drinker
• •18. For females only: pregnant or lactating women. Serum pregnancy test to be performed at screening and urine pregnancy test to be performed before the first dosing;
• •19. Subjects receiving treatment with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) within the previous 3 months before the screening visit
• •20. Subjects using e-cigarettes within 6 months before screening.
• •21. Positive documented COVID-19 test before admission