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An Open-Label Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of CRV431

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Trial Profile

An Open-Label Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of CRV431

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 07 Aug 2019

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At a glance

  • Drugs Rencofilstat (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Pharmacokinetics
  • Sponsors Hepion Pharmaceuticals

Most Recent Events

  • 29 Jul 2019 According to a Hepion Pharmaceuticals media release, the U.S. Food and Drug Administration has reviewed the IND application for CRV431 for the treatment of NASH and has authorized that the Company proceed with its planned IND opening study. The company expects to begin this trial in 2019.
  • 22 Jul 2019 According to a ContraVir Pharmaceuticals media release, the company has changed its name from Contravir Pharmaceuticals to Hepion Pharmaceuticals.
  • 27 Jun 2019 According to a ContraVir Pharmaceuticals media release, the company expect to receive confirmation that the IND submission has been accepted by the FDA, Center for Drug Evaluation and Research, in due course. This submission follows the compelling and positive preclinical and clinical work conducted to date, indicating that CRV431 offers a novel approach to treating NASH, with broader applications in liver disease.

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