Actively Recruiting
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Led by Zydus Therapeutics Inc. · Updated on 2026-02-17
30
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
CONDITIONS
Official Title
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Male or female aged 18 to 80 years inclusive
- Body mass index between 18.0 and 48.0 kg/m2 inclusive
- Females must be non-pregnant, non-lactating, and either not able to have children or using effective contraception throughout the study
- Females of childbearing potential and males must agree to use contraception during the study
- Able to swallow and keep oral medication
- For hepatic impairment groups (8 and 9): documented history of hepatic impairment with cirrhosis due to cholestatic liver disease classified by CPT score
- Laboratory test results for hepatic impairment groups must meet specified clinical parameters including ALT/AST ≤ 10 times upper limit of normal, ANC ≥ 750/mm3, platelets ≥ 25,000/mm3, hemoglobin ≥ 8 g/dL, and alpha-fetoprotein < 50 ng/mL or 50-80 ng/mL with negative imaging
- For normal hepatic function groups (8D and 9D): good health with no significant medical findings and normal or clinically acceptable lab values including ALT/AST < 1.2 times upper limit of normal
You will not qualify if you...
- Any significant or unstable medical condition that would prevent study participation
- History of any cancer in the last 3 years except certain non-invasive or excised skin cancers
- Stomach or intestinal surgery within 6 months that affects drug absorption, except some uncomplicated surgeries
- Significant drug allergy deemed relevant by the investigator
- Major surgery within 3 months prior to screening
- Blood donation within 3 months prior to screening
- Active infectious disease requiring systemic treatment or symptoms within 2 weeks prior to screening
- Use of medications affecting drug metabolism within 21 days prior to screening unless approved
- Participation in other investigational drug studies within 30 days or 5 half-lives before this study
- Estimated glomerular filtration rate below 60 mL/min/1.73 m2
- Positive alcohol breath test or substance abuse affecting compliance
- Positive drug abuse test unless due to prescribed medication
- Poor peripheral venous access
- Blood product receipt within 1 month prior to check-in
- HIV type 1 antibody positive
- Other liver diseases like NASH, alcoholic steatohepatitis, autoimmune or viral hepatitis
- Change in hepatic disease status within 30 days prior to screening
- History of gastrointestinal bleeding within 1 month prior to screening
- Current functioning organ transplant
- Severe ascites needing frequent paracentesis
- Use of over-the-counter or prescription medications within 30 days prior to enrollment except stable hormone or hepatic therapies
- For mild and moderate hepatic impairment groups: total bilirubin greater than 5 times upper limit of normal
- For normal liver function controls: use of prescription or over-the-counter medications within 14 days prior to dosing except certain vitamins or approved products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zydus US002
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
F
Farheen Shaikh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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