Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Zydus Therapeutics Inc.
Study ID
NCT05045482
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cholestatic Liver Disease
  • Cirrhosis
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Saroglitazar Magnesium 1 mg — DRUG
    Group-8: Total of 18 subjects will be enrolled in the Group-8. Group 8A (n=6, consist of mild hepatic impairment subjects); Group 8B (n=6, consist of moderate hepatic impairment), Group 8C (n=3, consist of severe hepatic impairment and Group 8D (n=3, consist of control subjects with normal hepatic functions).
  • Saroglitazar Magnesium 2 mg — DRUG
    Group-9: Total of 12 subjects will be enrolled in the Group-9. Group 9A (n=3, consist of mild hepatic impairment subjects); Group 9B (n=3, consist of moderate hepatic impairment), Group 9C (n=3, consist of severe hepatic impairment and Group 9D (n=3, consist of control subjects with normal hepatic functions).

Study Details

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

Key Dates

Start date
Oct 21, 2021
Status verified
Feb 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Saroglitazar Magnesium 1 mg
    The study drug will be administered from Day 1 to Day 28 once daily in the morning before breakfast without food. Study drug -Saroglitazar Magnesium tablets; Dosage form- Tablets (immediate release); Dose- 1 mg/day; Frequency- One tablet per day (in the morning before breakfast without food); Duration of treatment- 28 consecutive days
  • Experimental: Saroglitazar Magnesium 2 mg
    The study drug will be administered from Day 1 to Day 28 once daily in the morning before breakfast without food. Study drug -Saroglitazar Magnesium tablets: Dosage form- Tablets (immediate release); Dose- 2 mg/day; Frequency- One tablet per day (in the morning before breakfast without food); Duration- 28 consecutive days

Primary Outcome Measure

To evaluate the plasma PK of Saroglitazar (parent compound) [ Time Frame: 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zydus US002IndianapolisIndiana46202

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Zydus US002· Indianapolis, IN

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