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
Price :
$35
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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
- 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.