NCT06892756

Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study

Open-label, Non-randomised, Single-dose, One Sequence, Two-period, Cross-over Study to Investigate the Effect of Inhibition of P-glycoprotein and Breast Cancer Resistance Protein Transporters by Cyclosporine on the Pharmacokinetics of CHF6001 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	CHF6001 dry powder inhaler (DPI)	CHF6001 DPI single dose administration followed by a 14 to 17-day wash-out period before Treatment Period 2
DRUG	Cyclosporine	Oral cyclosporine single dose administration
DRUG	CHF6001 DPI	CHF6001 DPI single dose administration after oral cyclosporine single dose administration

Timeline

• Start date: 2025-03-18
• Primary completion: 2025-06-20
• Completion: 2025-06-20
• First posted: 2025-03-25
• Last updated: 2025-09-09

Locations

1 site across 1 country: Bulgaria