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A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of Tropifexor (LJN452) in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Control Subjects

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Trial Profile

A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of Tropifexor (LJN452) in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Control Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Nov 2021

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At a glance

  • Drugs Tropifexor (Primary)
  • Indications Hepatic fibrosis; Liver disorders; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis; Primary bile acid malabsorption; Primary biliary cirrhosis
  • Focus Pharmacokinetics
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 04 Nov 2021 Results assessing the effect of hepatic impairment, as determined by Child-Pugh grade, on tropifexors pharmacokinetics, safety, and tolerability following a 200 microgram dose in the fasted state, published in the Journal of Clinical Pharmacology.
  • 26 Jun 2021 Results evaluating safety and the effect of hepatic impairment (HI) on the systemic exposure of tropifexor presented at The International Liver Congress 2021
  • 28 Oct 2019 Status changed from recruiting to completed.

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