A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Zydus Therapeutics Inc.
Summary
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
Description
Hepatic impairment study in subjects with cirrhosis secondary to cholestatic disease at a single and multiple once daily doses of Saroglitazar Magnesium needs to be conducted per discussion with FDA. Thus, an extension study has been added.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: For all subjects: 1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF. 3. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening. 4. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study. 5. Females of child-bearing potential and males must agree to use contraception for the full duration of the study. 6. Ability to swallow and retain oral medicati…
Interventions
- DrugSaroglitazar Magnesium 1 mg
Group-8: Total of 18 subjects will be enrolled in the Group-8. Group 8A (n=6, consist of mild hepatic impairment subjects); Group 8B (n=6, consist of moderate hepatic impairment), Group 8C (n=3, consist of severe hepatic impairment and Group 8D (n=3, consist of control subjects with normal hepatic functions).
- DrugSaroglitazar Magnesium 2 mg
Group-9: Total of 12 subjects will be enrolled in the Group-9. Group 9A (n=3, consist of mild hepatic impairment subjects); Group 9B (n=3, consist of moderate hepatic impairment), Group 9C (n=3, consist of severe hepatic impairment and Group 9D (n=3, consist of control subjects with normal hepatic functions).
Location
- Zydus US002Indianapolis, Indiana