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The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taladegib | Drug | 100 mg per tablet, dosed once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 | |
| Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 | |
| Nintedanib absorption to time t (AUC0-t) after administration alone and after coadministration with ENV-101 (taladegib) | AUC represents "area under the concentration-time curve" and measures the amount of drug that is present in the blood from the time of administration to a given time t | Day 1 and Day 7 |
| Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 | |
| Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Frohna, M.D., Ph.D. | Endeavor Biomedicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C581399 | LY2940680 |
| C530716 | nintedanib |
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| nintedanib | Drug | 100 mg per capsule, dosed once daily |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |