NCT03004495

Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001

Open Label, Randomized, Repeated-dose, 3-way Crossover Study to Investigate Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001 Administered in Healthy Subjects Via NEXThaler® Dry Powder Inhaler

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of CHF6001 and CHF5259, in comparison with the single components, administered in healthy subjects via a multi-dose reservoir NEXThaler® DPI.

Detailed description

This is randomised open label, 3-way cross-over study. Each 14-day treatment period is separated from the following one by a 21-day wash-out period. Subjects will reside at the clinic facilities during the 14 days treatment period.

Conditions

• Copd

Interventions

Type	Name	Description
DRUG	CHF5259 and CHF6001	b.i.d. for 14 days
DRUG	CHF5259 + placebo	b.i.d. for 14 days
DRUG	CHF6001 + placebo	b.i.d. for 14 days
OTHER	Placebo	b.i.d. for 14 days

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-12-29
• Last updated: 2016-12-29

Locations

1 site across 1 country: United Kingdom