drugset / Trial / NCT03681457

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

NCT03681457

Phase 1 Completed 42 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-09-24
Primary completion
2019-09-25
Completion
2019-09-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Tropifexor Small molecule

Indications