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.
Trial 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… Read more about this study
- 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
- Are there results?
- None posted in the registry
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;
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- 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;
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- 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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maya Dabcheva, MD, Principal investigator, MC Comac Medical Ltd.
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06892756
- Acronym / sponsor ID
- DDI2 / CLI-06001AA1-06
- Keywords
- CHF6001, pharmacokinetics, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF6001 alone (Treatment Period 1) | Experimental | Drug: CHF6001 dry powder inhaler (DPI)CHF6001 DPI (dry powder inhaler) followed by a 14 to 17-day wash-out period before Period 2 |
| CHF6001 after Cyclosporine (Treatment Period 2) | Experimental | Drug: Cyclosporine, Drug: CHF6001 DPICyclosporine plus CHF6001 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CHF6001 alone (Treatment Period 1) |
| CyclosporineOral cyclosporine single dose administration | Drug | CHF6001 after Cyclosporine (Treatment Period 2) |
| CHF6001 DPICHF6001 DPI single dose administration after oral cyclosporine single dose administration | Drug | CHF6001 after Cyclosporine (Treatment Period 2) |
Primary outcome
Plasma CHF6001 AUC0-t
Time frame: 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
PK evaluation to determine concentrations of CHF6001 when administered alone or after cyclosporine
Plasma CHF6001 Cmax
Time frame: 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
PK evaluation to determine concentrations of CHF6001 when administered alone or after cyclosporine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Dabcheva, MD principal investigator
MC Comac Medical Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma CHF6001 AUC0-t (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.