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Tobira Therapeutics Announces Publication of Phase 1 Study Results Showing Cenicriviroc Safety in Cirrhotic Patients

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Additional Relevant Details The study evaluated the pharmacokinetics, pharmacodynamics and safety of CVC in participants with cirrhosis and mild or moderate hepatic impairment compared to healthy matched controls. Following once-daily administration of CVC 150 milligrams over 14 days, participants with mild hepatic impairment did not have increased exposures whereas those with moderate hepatic impairment had higher exposures (AUC0-t and Cmax increased by 55% and 29%, respectively). Exploratory analyses to evaluate pharmacodynamic effects of CVC on CCR2 and CCR5 ligands, proinflammatory cytokines and bacterial translocation biomarkers did not reveal any meaningful differences between participants with hepatic impairment and those with normal hepatic function. Furthermore, CVC was generally well tolerated, with adverse events consistent with its known safety profile.
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Catalyst Date
Occurred on:
May 13, 2016
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Related Keywords Non-alcoholic Steatohepatitis, Fibrotic Disease, Cenicriviroc, Cvc, Nash