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

NCT06825559 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SARO.24.003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholestatic Liver Disease

Keywords

Saroglitazar Magnesium; Primary Biliary Cholangitis; PBC; Pharmacokinetics

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetics of Saroglitazar: Cmax

  Maximum plasma concentration (Cmax)

  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

• Pharmacokinetics of Saroglitazar: Tmax

  Time to reach maximum plasma concentration (Tmax)

  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

• Pharmacokinetics of Saroglitazar: AUCt

  The area under plasma concentration vs. time curve till the last time point

  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

• Pharmacokinetics of Saroglitazar: AUCi

  The area under plasma concentration vs. time curve extrapolated to the infinity

  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

• Pharmacokinetics of Saroglitazar: Kel

  The elimination rate constant

  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

• Pharmacokinetics of Saroglitazar: AUCtau

  The area under plasma concentration vs. time curve in a 48 hours dosing interval

  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

• Pharmacokinetics of Saroglitazar: t1/2

  The elimination half-life

  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

• Pharmacokinetics of Saroglitazar: Vd/F

  The apparent volume of distribution

  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

• Pharmacokinetics of Saroglitazar: CL/F

  The apparent clearance

  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

Secondary Outcomes (11)

• Number of participants with adverse events [Safety and Tolerability]

  From baseline to End of study (35 days)

• Pharmacokinetics of Saroglitazar sulfoxide: Tmax

  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

• Pharmacokinetics of Saroglitazar sulfoxide: Cmax

  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

• Pharmacokinetics of Saroglitazar sulfoxide: CL/F

  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

• Pharmacokinetics of Saroglitazar sulfoxide: Vd/F

  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

Study Arms (1)

Saroglitazar Magnesium 1 mg

EXPERIMENTAL

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

Drug: Saroglitazar Magnesium 1 mg

Interventions

Saroglitazar Magnesium 1 mg DRUG

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

Also known as: Not any

Saroglitazar Magnesium 1 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
• Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
• Ability to swallow and retain oral medication.
• Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.
• Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening:
• 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)
• Must provide written informed consent and agree to comply with the trial protocol.

You may not qualify if:

• Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
• History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).
• History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
• The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
• Any major surgery within 3 months of screening.
• Donation of blood or blood products within 3 months of screening.
• Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
• Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
• Estimated glomerular filtration rate (\<45 mL/min/1.73 m2 by CKD-EPI 2021 formula at screening.
• Any individual with poor peripheral venous access.
• Receipt of blood products within 1 month of check in.
• Human immunodeficiency virus type 1 antibody positive at screening.
• Other known causes of liver disease, such as non-alcoholic steatohepatitis , alcoholic steatohepatitis, autoimmune hepatitis, or acute or chronic viral hepatitis (including Hepatitis B and C) as determined by the investigator and subject's medical records.
• Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the subject's medical history and deemed clinically significant by the investigator.
• Subjects having - History of gastrointestinal bleeding within 1 month of screening. Current functioning organ transplant. Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

Study Sites (1)

Zydus Site US001

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (1)

• Rodney P, Starzomski R. Constraints on the moral agency of nurses. Rhinology. 1993 Oct;69(9):23-6. No abstract available.

  PMID: 11652809 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

saroglitazar

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deven Parmar

  Zydus Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Farheen Shaikh

CONTACT

609-730-1900; fshaikh@zydustherapeutics.com

Deven Parmar

CONTACT

609-559-0765; dparmar@zydustherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: August 5, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)