Study drug in people with cirrhosis from blocked bile flow
Treatments studied
Part of Digestive system clinical trials.
This Phase 1 trial studies how saroglitazar magnesium works in people with liver scarring (cirrhosis) caused by a bile-flow problem. It helps doctors understand safety and how the body handles the medicine in this specific liver condition.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You can understand the study and sign the consent form.
- You’re between 18 and 80 years old, and your body size (BMI) is 18 to 48.
- You can safely swallow and keep down pills by mouth.
- If you’re able to get pregnant, you must not be pregnant or breastfeeding, and you must use very reliable birth control during the study; if not, you still must use birth control as instructed.
- For the cirrhosis-from-bile-problem groups, specific blood tests must be high enough/low enough for safety (including liver enzymes, blood counts, and a cancer blood test that fits the rules).
- You should not have other major causes of liver disease, recent major health changes, recent bleeding, severe fluid buildup needing frequent drainage, or certain recent surgeries/medications that affect drug handling.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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