NCT03942666

PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects

A Clinical Pharmacology Study to Evaluate the CHF 6532 Linearity After Single Oral Administrations of Four Doses of a Tablet Formulation Followed by an Evaluation of the Pharmacokinetic at Steady State Following the Repeated Open Label b.i.d. Administration at One Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Treatment A	tablet of CHF 6532
DRUG	Treatment B	tablet of CHF 6532
DRUG	Treatment C	tablet of CHF 6532
DRUG	Treatment D	tablet of CHF 6532
DRUG	Treatment E	Placebo tablet of CHF 6532
DRUG	Treatment F	tablet of CHF 6532

Timeline

• Start date: 2019-05-10
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2019-05-08
• Last updated: 2020-07-22

Locations

1 site across 1 country: Belgium