Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 … (NCT06892756) | Clinical Trial Compass
CompletedPhase 1
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
Bulgaria30 participantsStarted 2025-03-18
Plain-language summary
The main goal of this pharmacokinetic study in healthy volunteers is to evaluate the potential effect of cyclosporine (probe inhibitor of P glycoprotein \[P-gp\] and breast cancer resistance protein \[BCRP\] transporters) on CHF6001 (Tanimilast) systemic exposure following single dose administration, by comparing the area under the curve (AUC) from time 0 to the last quantifiable concentration (AUC0 t) and the maximum plasma concentration (Cmax) of CHF6001 with and without cyclosporine. Participants will receive CHF6001 alone in Treatment Period 1, then CHF6001 after oral cyclosporine in Treatment Period 2, in order to evaluate the cyclosporine drug interaction on CHF6001 systemic exposure. The two treatment periods will be separated by a wash out period of 14 to 17 days.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject's written informed consent obtained prior to any study related procedures;
✓. Healthy male and female subjects aged 18 55 years inclusive;
✓. Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly and to generate sufficient peak inspiratory flow;
✓. Body mass index between 18.0 and 30.0 kg/m2 extremes inclusive;
✓. Non- or ex smokers who smoked \<5 pack years;
✓. Good physical and mental status determined based on the medical history and a general clinical examination, at the Screening Visit and prior to the first dosing;
✓. Vital signs within normal limits at the Screening Visit;
✓. A 12-lead digitalised electrocardiogram (12-lead ECG) in triplicate considered as normal at the Screening Visit;)
Exclusion criteria
✕. Participation in another clinical study less than 8 weeks prior to the Screening Visit;
What they're measuring
1
Plasma CHF6001 AUC0-t
Timeframe: A total of 16 blood samples will be collected at the following time points: Pre-dose, and then 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours after CHF6001 administration
2
Plasma CHF6001 Cmax
Timeframe: A total of 16 blood samples will be collected at the following time points: Pre-dose, and then 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours after CHF6001 administration
✕. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic or psychiatric disorders, gastric surgery recently or in the past, and/or impaired gastric motility that may interfere with successful completion of this protocol according to the Investigator's judgment;
✕. Clinically relevant abnormal laboratory values at the Screening Visit suggesting an unknown disease and requiring further clinical investigation, or which may impact the safety of the subject or the evaluation of the results of the study according to the Investigator's judgment.
✕. Abnormal liver enzymes at the Screening Visit (alanine aminotransferase or aspartate aminotransferase \>1.5x upper limit of normal \[ULN\], bilirubin \>1.5x ULN).
✕. Subjects with history of breathing problems (e.g. history of asthma). Allergic asthma diagnosis in childhood (until 12 years old) is allowed;
✕. Positive human immunodeficiency virus (HIV) 1 or HIV2 serology at the Screening Visit;
✕. Positive results from the hepatitis serology which indicates acute or chronic hepatitis B (HB) or hepatitis C (HC) at the Screening Visit;
✕. Blood donation or blood loss (≥450 mL) less than 8 weeks prior to the Screening Visit (evaluated at the Screening Visit and before the first dosing);