NCT04469920

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

Evaluation of Pharmacokinetics and Safety of Saroglitazar Magnesium in Participants with Normal Hepatic Function and with Hepatic Impairment, Cholestatic Liver Disease, NASH with Advanced Fibrosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function

Detailed description

Male and female participants 18-80 years of age (inclusive) with normal hepatic function or hepatic impairment/disease who meet all of the inclusion and none of the exclusion criteria. Subjects with hepatic impairment will be enrolled based upon the Child-Pugh-Turcotte (CPT) classification system for mild hepatic impairment (Group 1 CPT Class A without PHT; Group 2 CPT Class A with PHT), moderate hepatic impairment (Group 3 Decompensated CPT Class B), or severe hepatic impairment (Group 4 Decompensated CPT Class C). Group 5 will include subjects with cholestatic liver disease and Group 6 will include subjects with non-cirrhotic advanced fibrosis secondary to NASH (non-alcoholic steatohepatitis). The control group (Group 7) will consist of demographic matched subjects with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Saroglitazar Magnesium 2 mg	1 tablet, single dose at Day 1
DRUG	Saroglitazar Magnesium 4 mg	1 tablet, single dose at Day 1

Timeline

• Start date: 2020-07-16
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2020-07-14
• Last updated: 2024-09-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study