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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515442-17-00 | EU Trial (CTIS) Number |
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The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study). The study will also evaluate the PK profile of study drug in plasma and urine after single and repeated administrations of CHF10073.
In addition, this study will also investigate the metabolites profile of CHF10073 in plasma, urine and faeces (Part 2 of the study) and the PK profile of CHF10073 in the lungs after bronchoalveolar lavage (BAL) (Part 3 of the study).
In addition, the effect of multiple doses of itraconazole on the pharmacokinetic profile of CHF10073 will be investigated (Part 4 of the study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF10073 active | Experimental |
| |
| placebo | Placebo Comparator |
| |
| CHF10073 + itraconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF10073 (Part 1 - SAD) | Drug | Single doses of CHF10073 for each cohort |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and adverse drug reactions | Through study completion, around 8 weeks in Part 1, from 10 to 13 weeks in Part 2, for about 7-8 weeks in Part 3 and for about 15 up to 17 weeks in Part 4 | |
| Vital signs (Systolic and diastolic Blood Pressure) | From screening up to 42 days post-dose | |
| Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR (heart rate), HR from 0 to 24 hours, hourly HR | From screening up to 28 days post-dose | |
| Absolute Values for 12-lead ECGs Recording of Intervals | Intervals recorded: PR, QRS, QT, QTcF | From screening up to 28 days post-dose |
| Change from Baseline for Post-dose 12-lead ECGs Recording of HR, HR from 0 to 24 hours, hourly HR | From screening up to 28 days post-dose | |
| Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals | Intervals recorded: PR, QRS, QT, QTcF | From screening up to 28 days post-dose |
| Number and percentage of subjects with abnormal actual QTcF (Fridericia-corrected QT Interval). | Part 1 and 2 only: From screening up to 28 days post-dose | |
| Number and percentage of subjects with abnormal change from the baseline of QTcF and HR from 0 to 24 hours | Part 1 and 2 only: From screening up to 28 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| CHF10073 plasma AUCinf (Area Under the Curve from time 0 Extrapolated to Infinity) | From first dosing up to 42 days post-dose | |
| CHF10073 plasma tmax (Time to Maximum Plasma Concentration) | From first dosing up to 42 days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jelle Klein, MD | SGS Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium NV Clinical Pharmacology Unit | Edegem | 2650 | Belgium |
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Part 1 - SAD (single ascending dose): Randomised, double-blind, placebo-controlled, single-dose escalation, parallel-group design in HVs.
Part 2 - MAD (multiple ascending dose): Randomised, double-blind, placebo-controlled, repeated-dose escalation, parallel-group design in HVs; Part 3: Non-randomised, open-label, single dose design in HVs Part 4 - Non-randomised, open-label, one-sequence, two-period crossover design in HVs.
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| Placebo (Part 1 - SAD) |
| Drug |
Single doses of placebo matching CHF10073 for each cohort |
|
| CHF10073 (Part 2 - MAD) | Drug | Multiple doses of CHF10073 for each cohort |
|
| CHF10073 (Part 3) | Drug | Single dose of CHF10073 |
|
| Placebo (Part 2 - MAD) | Drug | Multiple doses of placebo matching CHF10073 for each cohort |
|
| itraconazole (Part 4) | Drug | Multiple dose of itraconazole in treatment period 2 |
|
| CHF10073 (Part 4) | Drug | Single dose of CHF10073 in Treatment Period 1 and 2 |
|
| Number of subjects and percentages by treatment with abnormal parameters derived from 24h Holter ECG recording (total pauses >2.5 secs, atrial fibrillation and atrial flutter, ventricular runs, PAC burden, PVC burden and aberrant morphologies) | Part 1 and 2 only: From screening up to 28 days post-dose |
| Number of subjects with abnormal blood laboratory test results | Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics. | From screening up to 28 days post-dose |
| Number of subjects with abnormal urine laboratory test results | From screening up to 28 days post-dose |
| Spirometry (FEV1 (Forced exhalation volume in the first second)) | From screening up to 28 days post-dose |
| Cough recording: percentage of days with cough episodes during the treatment period | Part 2 only: From first dosing up to 28 days post-dose |
| Cough recording: average VAS (visual analogue scale)) | Part 2 only: From first dosing up to 28 days post-dose |
| CHF10073 plasma AUCt (Area Under the Curve from time 0 to time t) | From first dosing up to 42 days post-dose |
| CHF10073 plasma Cmax (Maximum Plasma Concentration) | From first dosing up to 42 days post-dose |
| CHF10073 plasma elimination half-life | From first dosing up to 42 days post-dose |
| CHF10073 plasma apparent clearance (CL/F) | From first dosing up to 42 days post-dose |
| CHF10073 plasma apparent volume of distribution (Vz/F) | From first dosing up to 42 days post-dose |
| CHF10073 urine amount excreted (Ae) | Part 1, 2 and 4 : From first dosing up to 28 days post-dose |
| CHF10073 urine faction excreted (fe) | Part 1, 2 and 4: From first dosing up to 28 days post-dose |
| CHF10073 renal clearance (CLr) | Part 1, 2 and 4: From first dosing up to 28 days post-dose |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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