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.

Start 17 Mar 2025 · End 20 Jun 2025 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol CLI-06001AA1-06

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 24

Countries 1

Sites 2

Chronic obstructive pulmonary disease

Key facts

Sponsor: Chiesi Farmaceutici S.p.A.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration: 17 Mar 2025 → 20 Jun 2025
Decision date (initial): 2025-02-06
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Chronic obstructive pulmonary disease

Version	Level	Code	Term	System organ class
26.1	PT	10009033	Chronic obstructive pulmonary disease	100000004855

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Chiesi Farmaceutici S.p.A.

Sponsor organisation: Chiesi Farmaceutici S.p.A.
Address: Via Palermo 26 A
City: Parma
Postcode: 43122
Country: Italy

Scientific contact point

Organisation: Chiesi Farmaceutici S.p.A.
Contact name: GLOBAL CLINICAL DEVELOPMENT

Public contact point

Organisation: Chiesi Farmaceutici S.p.A.
Contact name: GLOBAL CLINICAL DEVELOPMENT

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Ended	24	2
Rest of world	—	0	—

Investigational sites

Bulgaria

2 sites · Ended

Medical Center Comac Medical Ltd.

NAP, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia