Actively Recruiting
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Led by Zydus Therapeutics Inc. · Updated on 2025-10-24
6
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years at consent
- Body mass index between 18.0 and 48.0 kg/m2 at screening
- Ability to swallow and keep oral medication
- Documented moderate hepatic impairment with cirrhosis due to cholestatic liver disease with Child-Pugh score 7 to 9
- Laboratory tests within acceptable clinical limits including alkaline phosphatase above normal, liver enzymes less than or equal to 10 times normal, neutrophils at least 750/mm3, platelets at least 25,000/mm3, hemoglobin at least 8 g/dL, and alpha-fetoprotein below 50 ng/mL or 50-80 ng/mL with negative liver imaging
- Negative imaging for liver cancer within specified timeframes
- Able and willing to provide informed consent and comply with the study protocol
You will not qualify if you...
- Significant or unstable medical condition preventing participation
- History of cancer in last 3 years except certain non-invasive or excised skin cancers
- Stomach or intestinal surgery within 6 months that affects drug absorption (some minor surgeries allowed)
- History of severe drug allergy
- Major surgery within 3 months
- Blood donation within 3 months
- Active infection requiring treatment or symptoms within 2 weeks
- Use of investigational drugs within 30 days or 5 half-lives before study drug
- Kidney function with estimated filtration rate below 45 mL/min/1.73 m2
- Poor peripheral venous access
- Blood products received within 1 month
- Positive HIV-1 antibody test
- Other liver diseases like non-alcoholic or alcoholic steatohepatitis, autoimmune or viral hepatitis
- Recent change in hepatic disease status within 30 days
- History of gastrointestinal bleeding within 1 month
- Current functioning organ transplant
- Severe ascites needing frequent fluid removal
- Pregnancy or breastfeeding, or positive pregnancy test at screening
- Must use effective contraception or abstain during and for 1 month after the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zydus Site US001
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
F
Farheen Shaikh
CONTACT
D
Deven Parmar
CONTACT
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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