Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control Subjects

Inclusion criteria

• ✓. Subject's written informed consent obtained prior to any study-related procedure;
• ✓. Ability to understand the study procedures and the risks involved, and ability to be rained to use the inhalers correctly and to generate sufficient peak inspiratory flow (PIF; at least 40 L/min) using the In- Check DIAL set as per NEXThaler® inhaler resistance;
• ✓. 12-Lead digitised electrocardiogram (ECG) in triplicate considered as normal (40 beats per minute \[bpm\] ≤ heart rate \[HR\] ≤ 110 bpm, 120 ms ≤ PR interval \[PR\] ≤ 210 ms, QRS interval \[QRS\] ≤ 120 ms, QT Interval corrected using Fridericia's formula \[QTcF\] ≤ 450 ms for males and QTcF ≤ 470 ms for females) at screening visit. The mean value must be within the defined range;
• ✓. Male and female subjects aged 40 to 80 years inclusive;
• ✓. Subjects must weigh at least 45 kg for females and 50 kg for males to participate in the study, and must have a body mass index within the range of 18 to 35 kg/m2 inclusive;
• ✓. Non- or ex-smokers who smoked \< 5 pack-years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking \> 1 year prior to screening;
• ✓. Female subjects: a. Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use at least an acceptable effective birth control method from the signature of the informed consent and until study discontinuation; or ii. WOCBP with non-fertile male partners (contraception is not required in this case); b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile. Tubal ligation or partial surgical interventions are not acceptable.
• ✓. Vital signs within normal limits at screening: diastolic blood pressure (DBP) 40-89 mmHg and systolic blood pressure (SBP) 90-139 mmHg, extremes included (two measures performed after at least 5 minutes of resting).