An Open-Label, Single-Dose Trial to Assess the Effects of Hepatic Impairment on the Pharmacokinetics of Obeticholic Acid (OCA)

Trial Profile

An Open-Label, Single-Dose Trial to Assess the Effects of Hepatic Impairment on the Pharmacokinetics of Obeticholic Acid (OCA)

Completed
Phase of Trial: Phase I

Latest Information Update: 18 Mar 2017

At a glance

  • Drugs Obeticholic acid (Primary)
  • Indications Crohn's disease; Non-alcoholic steatohepatitis; Portal hypertension; Primary bile acid malabsorption; Primary biliary cirrhosis
  • Focus Pharmacokinetics
  • Sponsors Intercept Pharmaceuticals
  • Most Recent Events

    • 18 Mar 2017 Results evaluating evidences from NCT01904539, NCT01473524, NCT00550862, NCT00570765 trials to recommend appropriate dosing in treatment of primary biliary cholagitis, presented at the 118th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 31 Oct 2013 New trial record
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