A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF10073 After Single and Multiple Ascending Doses in Healthy Volunteers Via Inhalation and the Effect of Multiple Doses of Itraconazole on CHF10073 Exposure
The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study). The study will also evaluate the PK profile of study drug in plasma and urine after single and repeated administrations of CHF10073. In addition, this study will also investigate the metabolites profile of CHF10073 in plasma, urine and faeces (Part 2 of the study) and the PK profile of CHF10073 in the lungs after bronchoalveolar lavage (BAL) (Part 3 of the study). In addition, the effect of multiple doses of itraconazole on the pharmacokinetic profile of CHF10073 will be investigated (Part 4 of the study).
• Subject's written informed consent;
• Healthy male (Part 1 to 4) or female (Part 4) 18-55 years;
• Understanding of the study procedures and the correct use of the inhalers;
• BMI between 18.5 and 30.0 kg/m2;
• Non- or ex-smokers (\<5 pack-years and stopped smoking \>1 year prior to screening);
• Good physical and mental status;
• Vital signs within normal limits; body temperature \<37.5°C;
• 12-lead digitised ECG in triplicate considered as normal;
• Lung function measurements within normal limits;
• Males with pregnant or non-pregnant women of childbearing potential (WOCBP) partners must be willing to use contraception
• Part 4 only: women of non-childbearing potential (WONCBP) or WOCBP with fertile male parters willing to use contraception