RecruitingPhase 1NCT06825559

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease


Sponsor

Zydus Therapeutics Inc.

Enrollment

6 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Saroglitazar Magnesium 1 mg for people with cholestatic liver disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSaroglitazar Magnesium 1 mg

Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study


Locations(1)

Zydus Site US001

Indianapolis, Indiana, United States

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NCT06825559


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