Study on the Body Mass Balance and Biotransformation of [14C]-HEC585

Summary

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.

Timeline

Start

2022-07-26

Primary completion

2022-08-14

Completion

2022-08-29

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.