Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 21, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Hepatic ImpairmentCirrhosisCholestatic Liver Disease
Interventions
DRUG

Saroglitazar Magnesium 1 mg

Group-8: Total of 18 subjects will be enrolled in the Group-8. Group 8A (n=6, consist of mild hepatic impairment subjects); Group 8B (n=6, consist of moderate hepatic impairment), Group 8C (n=3, consist of severe hepatic impairment and Group 8D (n=3, consist of control subjects with normal hepatic functions).

DRUG

Saroglitazar Magnesium 2 mg

Group-9: Total of 12 subjects will be enrolled in the Group-9. Group 9A (n=3, consist of mild hepatic impairment subjects); Group 9B (n=3, consist of moderate hepatic impairment), Group 9C (n=3, consist of severe hepatic impairment and Group 9D (n=3, consist of control subjects with normal hepatic functions).

Trial Locations (1)

46202

RECRUITING

Zydus US002, Indianapolis

All Listed Sponsors
lead

Zydus Therapeutics Inc.

INDUSTRY