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

NCT06825559 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-10-24

No results posted yet for this study

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

Conditions

  • Cholestatic Liver Disease

Interventions

DRUG

Saroglitazar Magnesium 1 mg

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

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven Parmar · Zydus Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825559 on ClinicalTrials.gov