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NCT06825559
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Conditions: Cholestatic Liver Disease
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 6
Sponsor: Zydus Therapeutics Inc.
Location: Zydus Site US001 Indianapolis Indiana
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
Eligibility Criteria
Inclusion Criteria:
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 \
Source: ClinicalTrials.gov (NCT06825559). StuddyBuddy aggregates publicly available trial information.