Saroglitazar Magnesium for Cholestatic Liver Disease

Recruiting at 1 trial location

Overseen By Deven Parmar

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Zydus Therapeutics Inc.

Must not be taking: Antibiotics, Antifungals, Antivirals, others

Disqualifiers: Malignancy, Surgery, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Deven Parmar

Principal Investigator

Zydus Therapeutics Inc.

Eligibility Criteria

This trial is for adults with moderate liver impairment and cirrhosis due to cholestatic liver disease. They must have certain blood test results within specific ranges, no liver cancer, a BMI of 18-48 kg/m2, and the ability to swallow pills. Participants need to consent to follow the trial rules.

Inclusion Criteria

I can swallow and keep down pills.

I agree to participate in the trial and follow its rules.

Alkaline Phosphatase \> upper limit of normal Alanine aminotransferase/Aspartate aminotransferase value ≤ 10 × upper limit of normal Absolute neutrophil count ≥ 750/mm3 Platelets ≥ 25,000/mm3 Hemoglobin ≥ 8 g/dL α-fetoprotein \<50 ng/mL or 50-80 ng/mL with negative imaging study (Ultrasound \[US\], computed tomography scan \[CT\], Magnetic Resonance Imaging \[MRI\]). Imaging study that excluded presence of liver cancer (US in the preceding 6 months and CT or MRI in the preceding 1 year)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast, for the duration of treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Saroglitazar Magnesium

Trial Overview The study tests Saroglitazar Magnesium (1 mg taken every other day) in patients with moderate hepatic impairment from cholestatic liver diseases. It aims to understand how the drug moves through and affects these patients.

Participant Groups

Group I: Saroglitazar Magnesium 1 mg Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Zydus Therapeutics Inc.

Lead Sponsor

Trials

16

Recruited

1,100+