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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Zydus Therapeutics Inc.
Study ID
NCT06825559
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cholestatic Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Saroglitazar Magnesium 1 mg — DRUG
    Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study

Study Details

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

Key Dates

Start date
Aug 5, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Saroglitazar Magnesium 1 mg
    Saroglitazar Magnesium 1 mg tablet orally administered on alternate days in the morning before breakfast without food, for the duration of treatment (29 days)

Primary Outcome Measure

Pharmacokinetics of Saroglitazar: Cmax [ Time Frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zydus Site US001IndianapolisIndiana46202

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Zydus· Indianapolis, IN

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