The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.
This clinical trial is a single centre, single dose Phase I study, with a non-randomized, open label, one sequence cross-over design. A total of 24 healthy male and female are planned to be included. Participants will be dosed with CHF6001 before and during co-administration of Itraconazole and will act as their own control. The study will be run with a one-sequence crossover design, where all subjects will be treated with CHF6001 in the first treatment period and CHF6001+Itraconazole in the second treatment period in order to avoid the need of a very long washout from the CYP3A4/5 inhibitor. Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood samples will be also collected for PK analysis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Single dose of CHF6001
Repeated doses of oral Itraconazole
SGS Life Sciences - Clinical Pharmacology Unit Antwerpen
Antwerp, Belgium
Pharmacokinetic parameter (Cmax)
Peak Plasma Concentration (Cmax) for CHF6001
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUCt)
Area under the plasma concentration versus time curve (AUCt) for CHF6001
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUC0-96)
Area under plasma concentration from 0 to 96 hours (AUC0-96) for CHF6001, CHF5956 and CHF6095
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUC0-∞)
Area under curve extrapolated to infinity (AUC0-∞) for CHF6001, CHF5956 and CHF6095
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (tmax)
Time of the maximum plasma concentration (tmax) for CHF6001, CHF5956 and CHF6095
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (t1/2)
Terminal half-life (t1/2) for CHF6001, CHF5956 and CHF6095
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (CL/F)
Apparent systemic clearance (CL/F) for CHF6001
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (AUCt)
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Area under the plasma concentration versus time curve (AUCt) for CHF5956 and CHF6095
Time frame: Over 96 hours after administration in blood
Pharmacokinetic parameter (Cmax)
Peak Plasma Concentration (Cmax) for CHF5956 and CHF6095
Time frame: Over 96 hours after administration in blood