Study of Saroglitazar Magnesium for Liver Impairment with Cirrhosis
This study is looking at how the body handles two different doses of Saroglitazar Magnesium (1 mg and 2 mg) in people with liver impairment (hepatic impairment) and cirrhosis due to cholestatic liver disease. Researchers want to understand how the drug moves through the body (pharmacokinetics or PK) and if it is safe and well-tolerated. The study plans to enroll 30 participants aged 18 to 80 years old. Success will be measured by how Saroglitazar and its breakdown product (metabolite) are found in the blood over time, and by tracking any side effects. The current enrollment status is unclear.
- Study design
- This is an open-label study, meaning both you and the study team will know which dose of Saroglitazar Magnesium you are receiving. It plans to enroll 30 participants.
- What's involved
- You would have blood samples taken on Day 1 and Day 28 to measure the drug levels. Your safety and tolerability will be monitored throughout the study, which is expected to last an average of 9 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability will be assessed through study completion, which is an average of 9 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Deven V Parmar, MD, FCP · STUDY_DIRECTOR · Zydus Therapeutics Inc.
Who to contact
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What this trial measures
- To evaluate the plasma PK of Saroglitazar (parent compound)Serial PK blood samples will be collected on Day1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)
To measure the plasma concentration of Saroglitazar (parent compound) and estimate the AUCt following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function.
- To assess the safety and tolerability of SaroglitazarThrough study completion, an average of 9 weeks
Percentage of subjects with clinical \& laboratory AEs/SAEs and Treatment emergent AEs/SAEs, coded using the MedDRA following single and once a daily multiple oral doses of 1 mg and 2 mg of Saroglitazar Magnesium in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function
- To evaluate plasma PK of Saroglitazar metabolite (Saroglitazar sulfoxide)Serial PK blood samples will be collected on Day 1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)
To measure the plasma concentration of Saroglitazar metabolite (Saroglitazar sulfoxide) and estimate the AUCt following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function.
- To evaluate the impact of hepatic impairment with cirrhosis due to cholestatic liver disease on the unbound concentration of Saroglitazar in systemic circulationThe blood samples will be collected on Day 1 and Day 28 at pre-dose, 2.0 h and 24.0 h post dose.
To measure the differences (between day-01 and Day-28) on unbound concentration of Saroglitazar in systemic circulation following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function
- To evaluate the trough plasma concentration of Saroglitazar (parent compound)Trough plasma sample will be collected at pre-dose on Visit 3 (on day 8), Visit-4 (On day 15) and at Visit 5 (on day 22). Additional PK sample will be collected at 168.0 hours post dose of day 28 (i.e. on Day 35 ±3D)
To evaluate the trough plasma concentration of Saroglitazar following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function
- To determine the plasma PK of Saroglitazar (parent compound)Serial PK blood samples will be collected on Day1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)
The plasma concentration of Saroglitazar (parent compound) will be measured to estimate the Cmax following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function.
- To determine the plasma PK of Saroglitazar metabolite (Saroglitazar sulfoxide)Serial PK blood samples will be collected on Day 1 and Day 28 (1 pre-dose sample and serial post dose sampling till 24 hours post dose on both days)
The plasma concentration of Saroglitazar metabolite (Saroglitazar sulfoxide) will be measured to estimate the Cmax following single and once a daily multiple oral doses of 1 mg and 2 mg in subjects with mild, moderate and severe hepatic impairment with cirrhosis due to cholestatic liver disease based on Child-Pugh-Turcotte score compared to subjects with normal hepatic function.