RecruitingHepatic ImpairmentCirrhosisCholestatic Liver Disease

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Eligible age

18–80 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

Sponsor: Zydus Therapeutics Inc.

✓ 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 medication.
✓ For Subjects in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):

✕ For all subjects:
✕ 1. Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.
✕ 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 the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
✕ 4. 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 prior to screening.
✕ 7. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.

Indianapolis

Source: ClinicalTrials.gov · NCT05045482 · last updated 2026-07-28