Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
ID06825559

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

Led by Zydus Therapeutics Inc. · Updated on 2025-10-24

6

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium 1 mg given every other day to adults with moderate hepatic impairment and cirrhosis caused by cholestatic liver disease. This phase 1, open-label, single-arm study aims to understand how this medication behaves in the body and its safety profile in this specific liver condition. Participants will receive Saroglitazar Magnesium 1 mg tablets orally every other day in the morning before breakfast without food for 29 days. The study involves detailed pharmacokinetic sampling at multiple time points on Day 1 and Day 29 to measure drug concentrations and related parameters. Researchers will also monitor safety and tolerability throughout the treatment period. During the study, participants will undergo blood sampling at various intervals up to 48 hours after dosing on Days 1 and 29 to assess drug levels and metabolism. Safety evaluations will include monitoring adverse events and laboratory tests from baseline to the end of the study at 35 days. The main outcomes focus on pharmacokinetic measures such as peak concentration, time to peak, and drug clearance, along with changes in liver function markers.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and/or female aged 18 to 80 years at the time of signing informed consent.
  • Body mass index (BMI) between 18.0 and 48.0 kg/m2 at screening.
  • Ability to swallow and retain oral medication.
  • Documented history of moderate hepatic impairment with cirrhosis due to cholestatic liver disease with Child-Pugh Turcotte score 7 to 9.
  • Laboratory tests within specified clinically acceptable ranges, including alkaline phosphatase above normal limit, amino transferase values less than or equal to 10 times the upper limit, adequate neutrophil count, platelets, hemoglobin, and alpha-fetoprotein levels.
  • Imaging studies excluding liver cancer within defined time frames.
  • Ability and willingness to provide written informed consent and comply with the study protocol.
Not Eligible

You will not qualify if you...

  • Any significant or unstable medical condition that would prevent participation.
  • History of malignancy within the last 3 years except certain skin or in situ cancers.
  • Surgery involving stomach or intestines within 6 months that may alter drug absorption, except uncomplicated procedures.
  • History of severe drug allergy such as anaphylaxis.
  • Major surgery within 3 months.
  • Blood or blood product donation within 3 months.
  • Active infection requiring treatment or symptoms within 2 weeks.
  • Recent use of investigational drugs within 30 days or 5 half-lives.
  • Poor peripheral venous access.
  • Receipt of blood products within 1 month.
  • Positive HIV-1 antibody test.
  • Other liver diseases like non-alcoholic or alcoholic steatohepatitis, autoimmune or viral hepatitis.
  • Changes in hepatic disease status within 30 days deemed significant.
  • Recent gastrointestinal bleeding, functioning organ transplant, or severe ascites needing frequent draining.
  • Pregnancy or lactation; pregnancy prevention required during and for 1 month after the study.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 29 days

Participants take Saroglitazar Magnesium 1 mg orally on alternate days in the morning before breakfast without food to evaluate pharmacokinetics, safety, and tolerability.

Multiple visits for pharmacokinetic sampling on Day 1 and Day 29

Follow-up

Duration - 6 days

Participants are monitored for safety and tolerability after completing treatment.

Visits as needed for safety assessments until Day 35

Trial Site Locations

Total: 1 location

1

Zydus Site US001

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

F

Farheen Shaikh

D

Deven Parmar

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Pharmacokinetic, Safety, and Pharmacodynamic Profiles of Saroglitazar Magnesium in Cholestatic Cirrhosis With Hepatic Impairment and Participants With Renal Impairment.

Raj Vuppalanchi, Mary M Cruz, Taufik Momin...

https://pubmed.ncbi.nlm.nih.gov/39355940