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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516475-32-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF6001 alone (Treatment Period 1) | Experimental | 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 | Cyclosporine plus CHF6001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma CHF6001 AUC0-t | PK evaluation to determine concentrations of CHF6001 when administered alone or after cyclosporine | 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 | 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 |
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Inclusion Criteria:
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;
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:
Females fulfilling one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maya Dabcheva, MD | MC Comac Medical Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Centre Comac Medical Ltd | Sofia | 1612 | Bulgaria |
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| Cyclosporine | Drug | Oral cyclosporine single dose administration |
|
| CHF6001 DPI | Drug | CHF6001 DPI single dose administration after oral cyclosporine single dose administration |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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