RecruitingCholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: Zydus Therapeutics Inc.
You may qualify if…
- ✓ 1. Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
- ✓ 2. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
- ✓ 3. Ability to swallow and retain oral medication.
- ✓ 4. 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.
- ✓ 5. 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)
- ✓ 6. Must provide written informed consent and agree to comply with the trial protocol.
You may not qualify if…
- ✕ 1. Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
- ✕ 2. 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).
- ✕ 3. 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).
- ✕ 4. The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
- ✕ 5. Any major surgery within 3 months of screening.
- ✕ 6. Donation of blood or blood products within 3 months of screening.
- ✕ 7. Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
- ✕ 8. Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
Where it's recruiting
Indiana
Indianapolis
Source: ClinicalTrials.gov · NCT06825559 · last updated 2026-09-14