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This is a single-centre, open-label, non-randomised, single-dose study in healthy male subjects designed to assess the mass balance and biotransformation of [14C]-HEC-585.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-HEC585 | Experimental | [14C]-HEC585,solid powder,200 mg/100 µCi,single dose,oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-HEC585 | Drug | Single Dose = Solution containing 200 mg/100 µCi [14C]-HEC585 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance | To determine the mass balance recovery of orally administered [14C]-HEC585 | plasma up to 312 hours post dose, urine and fecal samples up to 504 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of HEC-585 and its major metabolites | Analyze the Peak Plasma Concentration (Cmax) of HEC-585 and its major metabolites (if applicable) to obtain the corresponding pharmacokinetic parameters; | 312 hours |
| Area under the plasma concentration versus time curve (AUC) of HEC-585 and its major metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25976683 | Background | Hutchinson J, Fogarty A, Hubbard R, McKeever T. Global incidence and mortality of idiopathic pulmonary fibrosis: a systematic review. Eur Respir J. 2015 Sep;46(3):795-806. doi: 10.1183/09031936.00185114. Epub 2015 May 14. | |
| 30578336 | Background | Olson AL, Gifford AH, Inase N, Fernandez Perez ER, Suda T. The epidemiology of idiopathic pulmonary fibrosis and interstitial lung diseases at risk of a progressive-fibrosing phenotype. Eur Respir Rev. 2018 Dec 21;27(150):180077. doi: 10.1183/16000617.0077-2018. Print 2018 Dec 31. |
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|---|---|
| Related Info | View source |
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Analyze the Area under the plasma concentration versus time curve (AUC) of HEC-585 and its major metabolites (if applicable) to obtain the corresponding pharmacokinetic parameters; |
| 312 hours |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | To investigate the safety and tolerability of HEC585 by assessment of Incidence of Treatment-Emergent Adverse Events following administration of of oral dose of 200 mg/100 µCi[14C]-HEC-585 | 504 hours |
| 26399999 | Background | Richeldi L, Rubin AS, Avdeev S, Udwadia ZF, Xu ZJ. Idiopathic pulmonary fibrosis in BRIC countries: the cases of Brazil, Russia, India, and China. BMC Med. 2015 Sep 24;13:237. doi: 10.1186/s12916-015-0495-0. |
| 30527428 | Background | Ingegnoli F, Ughi N, Mihai C. Update on the epidemiology, risk factors, and disease outcomes of systemic sclerosis. Best Pract Res Clin Rheumatol. 2018 Apr;32(2):223-240. doi: 10.1016/j.berh.2018.08.005. Epub 2018 Sep 14. |
| 23203815 | Background | Hoffmann M, Kasserra C, Reyes J, Schafer P, Kosek J, Capone L, Parton A, Kim-Kang H, Surapaneni S, Kumar G. Absorption, metabolism and excretion of [14C]pomalidomide in humans following oral administration. Cancer Chemother Pharmacol. 2013 Feb;71(2):489-501. doi: 10.1007/s00280-012-2040-6. Epub 2012 Dec 1. |
| 21859393 | Background | Hoffmann M, Kumar G, Schafer P, Cedzik D, Capone L, Fong KL, Gu Z, Heller D, Feng H, Surapaneni S, Laskin O, Wu A. Disposition, metabolism and mass balance of [(14)C]apremilast following oral administration. Xenobiotica. 2011 Dec;41(12):1063-75. doi: 10.3109/00498254.2011.604745. Epub 2011 Aug 23. |
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