The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration at one dose.
The study consists in two parts. The first study part (Part I) is a single dose, randomised, double-blind, placebo-controlled, 5-way, 5-period crossover design, in healthy subjects. The second study part (Part II) is a repeated dose, open label treatment in healthy subjects. The PK of CHF 6532 and CHF 6532 acyl glucuronide metabolite (CHF 6532-AG), the cardiac safety will be assessed after single or repeated administration of CHF 6532 tablet formulations in healthy subjects under fed conditions. A total of 30 healthy male and female are planned to be included where they will participate the 2 study parts. 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 and urines samples will be also collected for PK analysis. Holter recordings will be performed to build a prospective concentration-response model of QTc for CHF 6532 in Part I and for cardiac safety purpose at steady state in Part II.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
30
SGS Life Sciences - Clinical Pharmacology Unit Antwerpen
Antwerp, Belgium
PK linearity of CHF 6532
Assessment of CHF 6532 PK linearity in blood and urine depending on increasing doses of CHF 6532
Time frame: Over 12 hours after administration in urine, over 48 hours after administration in blood
Steady state PK of CHF 6532
Assessment of CHF 6532 PK in blood and urine after a repeated administration of CHF 6532
Time frame: Over 12 hours after administration at Day 1 and Day 10 in urine, over 12 hours after administration at Day 1 and over 24 hours after administration at Day 10 in blood
Cardiac Safety of CHF 6532
Holter recording
Time frame: Over 24 hours after single administration in Part I, Over 24 hours at Day 10 in Part II
PK linearity of CHF 6532-AG
Assessment of CHF 6532-AG PK in blood and urine depending on increasing doses of CHF 6532
Time frame: Over 12 hours after administration in urine, over 48 hours after administration in blood
Steady state PK of CHF 6532-AG
Assessment of CHF 6532-AG PK in blood and urine after a repeated administration of CHF 6532
Time frame: Over 12 hours after administration at Day 1 and Day 10 in urine, over 12 hours after administration at Day 1 and over 24 hours after administration at Day 10 in blood
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
tablet of CHF 6532
Placebo tablet of CHF 6532
tablet of CHF 6532