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Clinical Trial NCT06825559 for Cholestatic Liver Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease Phase 1 6
Clinical Trial NCT06825559 is designed to study Treatment for Cholestatic Liver Disease. It is a Phase 1 interventional study that is recruiting, having started on 5 August 2025, with plans to enroll 6 participants. Led by Zydus Therapeutics Inc., it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 24 October 2025.
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
Detailed Description
A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Official Title
A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Conditions
Cholestatic Liver DiseasePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- SARO.24.003
NCT ID Number
Start Date (Actual)
2025-08-05
Last Update Posted
2025-10-24
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
6
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Saroglitazar Magnesium
Primary Biliary Cholangitis
PBC
Pharmacokinetics
Primary Biliary Cholangitis
PBC
Pharmacokinetics
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSaroglitazar 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) | Saroglitazar Magnesium 1 mg Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of participants with adverse events [Safety and Tolerability] | Number of participants with adverse events | From baseline to End of study (35 days) |
Pharmacokinetics of Saroglitazar sulfoxide: Tmax | Time to reach maximum plasma concentration | 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 | Maximum plasma concentration | 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 | 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 |
Pharmacokinetics of Saroglitazar sulfoxide: 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 sulfoxide: 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 sulfoxide: 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 sulfoxide: 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 sulfoxide: 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 sulfoxide: AUCt | 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 |
Change from baseline in alkaline phosphatase levels | From baseline to end of treatment (29 days) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
- 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.
- Pregnancy-related exclusions, including:
Pregnant/lactating female (including positive pregnancy test at screening) Pregnancy should be avoided by male and female subjects either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.
Zydus Therapeutics Inc.Study Central Contact
Contact: Farheen Shaikh, 609-730-1900, [email protected]
Contact: Deven Parmar, 609-559-0765, [email protected]
1 Study Locations in 1 Countries
Indiana
Zydus Site US001, Indianapolis, Indiana, 46202, United States
Mandy Cruz, Contact, [email protected]
Recruiting