PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers (NCT05431426) | Clinical Trial Compass
CompletedPhase 1
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
Bulgaria44 participantsStarted 2022-07-29
Plain-language summary
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same setting.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject's written informed consent obtained prior to any study-related procedure;
✓. Male and female subjects aged 40 to 80 years inclusive at screening;
✓. Ability to understand the study procedures and the risks involved, and ability to be trained to use the inhalers correctly and to generate sufficient peak inspiratory flow (PIF, at least 40 L/min) using the In-Check device set as per NEXThaler® inhaler resistance;
✓. Subjects must weigh at least 45kg for females and 50 kg for males to participate in the study, and must have a body mass index (BMI) 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;
✓. Oral body temperature \< 37.5°C;
✓. Mean values of triplicate recording of 12-lead digitised electrocardiogram (ECG) considered as normal (40 beats per min \[bpm\] ≤ 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);
✓. Lung function measurements within normal limits at screening: forced expiratory volume within the first second (FEV1) \> 80% predicted and FEV1/Forced vital capacity (FVC) ratio \> 0.70;
Exclusion criteria
✕. Participation to another clinical study where an investigational treatment was received, and last investigations were performed less than 8 weeks prior to screening;
What they're measuring
1
Area under the Curve (AUC) of total plasma CHF6001
Timeframe: Over 240 hours after CHF6001 administration
2
Maximum of Concentration (Cmax) of total plasma CHF6001
Timeframe: Over 240 hours after CHF6001 administration
✕. Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
✕. Positive human immunodeficiency virus (HIV) 1 or HIV2 serology;
✕. Positive results from the Hepatitis serology which indicates acute or chronic hepatitis B or hepatitis C at screening (i.e. positive hepatitis B surface antigen \[HBsAg\], hepatitis B core antibody \[immunoglobulin M antibody to hepatitis B core antigen, IgM anti-HBc\], hepatitis C virus \[HCV\] antibody);
✕. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks, or complications from this disease, which have not resolved within 14 days prior to screening or to study treatment administration;
✕. Blood donation or blood loss (≥ 450 mL) less than 2 months prior to screening or prior to study treatment administration;
✕. Abnormal liver enzymes at screening (alanine aminotransferase \[ALT\] or Aspartate aminotransferase \[AST\] \> 1.5 times the upper limit of normal \[ULN\], total bilirubin \> 1.5 times the ULN);
✕. Current haemodialysis or peritoneal dialysis or indications for these procedures;