Chronic Obstructive Pulmonary Disease (COPD)Phase 1DDI2NCT06892756

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

A Phase 1 study testing CHF6001 dry powder inhaler (DPI), Cyclosporine and CHF6001 DPI in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: CHF6001 dry powder inhaler (DPI), Cyclosporine and CHF6001 DPI
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteBulgaria
Study dates: 18 Mar 2025to 20 Jun 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject's written informed consent obtained prior to any study related procedures;
Healthy male and female subjects aged 18 55 years inclusive;
Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly and to generate sufficient peak inspiratory flow;
Body mass index between 18.0 and 30.0 kg/m2 extremes inclusive;
Non- or ex smokers who smoked <5 pack years;
Good physical and mental status determined based on the medical history and a general clinical examination, at the Screening Visit and prior to the first dosing;

Show all 16Show fewer

Vital signs within normal limits at the Screening Visit;
A 12-lead digitalised electrocardiogram (12-lead ECG) in triplicate considered as normal at the Screening Visit;)
Pulmonary function test within normal limits at the Screening Visit;
Males fulfilling one of the following criteria:
Males with pregnant or non-pregnant women of childbearing potential (WOCBP) partners: They must be willing to use male condom from the signature of the informed consent and until the Follow up Call; or
Non fertile male subjects: Contraception is not required in this case; or
Males with women of non childbearing potential (WONCBP) partners: Contraception is not required in this case;
Females fulfilling one of the following criteria:
WONCBP defined as physiologically incapable of becoming pregnant. Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per Investigator's request, post menopausal status may be confirmed by follicle stimulating hormone levels;
WOCBP fulfilling one of the following criteria: i. WOCBP with fertile male partners: They and/or their partner must be willing to use a highly effective birth control method preferably with low user dependency from the signature of the informed consent and until the Follow up Call; or ii. WOCBP with non fertile male partners: Contraception is not required in this case.

Who cannot join

Participation in another clinical study less than 8 weeks prior to the Screening Visit;
Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic or psychiatric disorders, gastric surgery recently or in the past, and/or impaired gastric motility that may interfere with successful completion of this protocol according to the Investigator's judgment;
Clinically relevant abnormal laboratory values at the Screening Visit suggesting an unknown disease and requiring further clinical investigation, or which may impact the safety of the subject or the evaluation of the results of the study according to the Investigator's judgment.
Abnormal liver enzymes at the Screening Visit (alanine aminotransferase or aspartate aminotransferase >1.5x upper limit of normal [ULN], bilirubin >1.5x ULN).
Subjects with history of breathing problems (e.g. history of asthma). Allergic asthma diagnosis in childhood (until 12 years old) is allowed;
Positive human immunodeficiency virus (HIV) 1 or HIV2 serology at the Screening Visit;

Show all 19Show fewer

Positive results from the hepatitis serology which indicates acute or chronic hepatitis B (HB) or hepatitis C (HC) at the Screening Visit;
Blood donation or blood loss (≥450 mL) less than 8 weeks prior to the Screening Visit (evaluated at the Screening Visit and before the first dosing);
Positive urine test for cotinine at the Screening Visit and/or prior to the first dosing;
Documented history of alcohol abuse within 12 months prior to the Screening Visit or a positive alcohol breath test at the Screening Visit and/or prior to the first dosing;
Documented history of drug abuse within 12 months prior to the Screening Visit or a positive urine drug screen evaluated at the Screening Visit and/or prior to the first dosing;
Presence of any current infection, or previous infection that resolved less than 7 days prior to the Screening Visit and prior to the first dosing.
Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
Unsuitable arm veins for repeated venipuncture;
Heavy caffeine drinker (>5 cups or glasses of caffeinated beverages, e.g. coffee, tea, cola per day);
For females only: Pregnant or lactating women;
Subjects using e-cigarettes within 6 months before the Screening Visit;
Positive test for coronavirus disease 2019 (antibody test or nucleic acid test) within 14 days prior to the Screening Visit and the associated complications/symptoms, which have not resolved within 14 days prior to the Screening Visit;
Intake of non-permitted concomitant medications in the predefined period prior to screening.

Trial locations and contacts

1 site in 1 country.

Bulgaria1 site

Medical Centre Comac Medical Ltd
Sofia, 1612

Other trials in Bulgaria

About this study

Official title: 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

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)
Being tested: CHF6001 dry powder inhaler (DPI), Cyclosporine, CHF6001 DPI
Keywords: CHF6001, pharmacokinetics, healthy volunteers
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHF6001 dry powder inhaler (DPI)Drug
CHF6001 DPI single dose administration followed by a 14 to 17-day wash-out period before Treatment Period 2
CyclosporineDrug
Oral cyclosporine single dose administration
CHF6001 DPIDrug
CHF6001 DPI single dose administration after oral cyclosporine single dose administration

Study groups in NCT06892756
Study group	Role	What they receive
CHF6001 alone (Treatment Period 1)	Experimental	CHF6001 DPI (dry powder inhaler) followed by a 14 to 17-day wash-out period before Period 2 Receives: Drug: CHF6001 dry powder inhaler (DPI)
CHF6001 after Cyclosporine (Treatment Period 2)	Experimental	Cyclosporine plus CHF6001 Receives: Drug: Cyclosporine; Drug: CHF6001 DPI

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma CHF6001 AUC0-t
PK evaluation to determine concentrations of CHF6001 when administered alone or after cyclosporine
Measured: A total of 16 blood samples will be collected at the following time points: Pre-dose, and then 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours after CHF6001 administration
Plasma CHF6001 Cmax
PK evaluation to determine concentrations of CHF6001 when administered alone or after cyclosporine
Measured: A total of 16 blood samples will be collected at the following time points: Pre-dose, and then 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours after CHF6001 administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202520 Jun 2025

First posted25 Mar 2025
Study start18 Mar 2025
Primary completion20 Jun 2025
Study completion20 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06892756
Sponsor's protocol ID: CLI-06001AA1-06
Other IDs: 2024-516475-32-00
Acronym: DDI2
Status last verified: Sep 2025
First submitted: 5 Mar 2025
Last updated: 9 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 2
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
COPD (Chronic Obstructive Pulmonary Disease)
RecruitingObservational study
A Study on COPD Phenotypes, Endotypes and Treatable Traits
Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruitingObservational study
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis

All Chronic Obstructive Pulmonary Disease (COPD) trials