NCT03681457

Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects

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: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	LJN452	Dose A single dose

Timeline

• Start date: 2018-09-24
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2018-09-24
• Last updated: 2020-12-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study