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A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEC585 and Pirfenidone | Experimental | The DDI study of HEC585 and Pirfenidone |
|
| HEC585 and Nintedanib | Experimental | The DDI study of HEC585 and Nintedanib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC585 | Drug | DDI of HEC585 and Pirfenidone:HEC585, once daily,D5-D14 and D18-D27; DDI of HEC585 and Nintedanib:HEC585,once daily,D14-D23 and D27-D36 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from 0 to 24 hours [AUC (0~24)] | Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone | Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase. |
| Maximum Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585 | Day 3 for Pirfenidone monotherapy phase; Day 14 for HEC585 monotherapy phase; Day 27 for Combination phase. |
| Area under the curve from 0 to 24 hours [AUC (0~24)] | Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Nintedanib | Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase. |
| Observed Plasma Concentration (Cmax) | Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib | Day 7 for Nintedanib monotherapy phase; Day 23 for HEC585 monotherapy phase; Day 36 for Combination phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0 | up to 31 days(HEC585 and Pirfenidone) |
| Incidence of treatment-emergent adverse events (TEAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
| C093844 | pirfenidone |
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| Nintedanib | Drug | DDI of HEC585 andNintedanib:Nintedanib,twice a day,D1-D7 and D30-D36 |
|
| Pirfenidone | Drug | DDI of HEC583 and Pirfenidone: Pirfenidone:three times a day,D1-D3 and D25-D27 |
|
Incidence of treatment-emergent adverse events (TEAEs)assessed by CTCAE V5.0
| up to 40 days(HEC585 and Nintedanib) |