Phase 1 Primary Biliary Cholangitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 80 years old (inclusive)
• Your body weight is in a healthy range for your height — specifically, your BMI is between 18.0 and 48.0
• You are able to swallow and keep down oral (by mouth) medication
• You have a documented history of liver scarring (cirrhosis) caused by a liver disease related to bile flow problems (cholestatic liver disease), with a specific liver severity score (Child-Pugh score) of 7 to 9, indicating moderate liver impairment
• Your blood test results at the screening visit fall within certain acceptable ranges for liver enzymes, blood cell counts, and a cancer marker called alpha-fetoprotein — and recent imaging (ultrasound, CT, or MRI) has shown no signs of liver cancer
• You are willing and able to give written consent and follow the study rules

Who may not be able to join:

• You have an unstable or serious health condition that the study doctor feels would make participation unsafe
• You have been diagnosed with cancer in the last 3 years (with some exceptions: certain early-stage cervical or breast cancers, or certain skin cancers that have been surgically removed)
• You have had stomach or intestinal surgery within the last 6 months that could affect how your body absorbs medication (minor procedures like appendix removal or hernia repair are generally allowed)
• You have a history of a serious allergic reaction to a drug (such as anaphylaxis) that the doctor considers relevant
• You have had major surgery within the last 3 months
• You have donated blood or blood products within the last 3 months
• You currently have an active infection requiring antibiotic, antifungal, or antiviral treatment, or had infection symptoms within the last 2 weeks
• You have taken part in another clinical trial or received an experimental drug within the last 30 days (or longer, depending on the drug)
• Your kidneys are not functioning well enough, based on a specific blood test measurement (confirm with trial site)
• You have poor vein access, making it difficult to take blood samples
• You have received blood products within the last month
• You have tested positive for HIV
• Your liver disease is caused by something other than cholestatic liver disease — for example, conditions related to alcohol, autoimmune disease, or viral hepatitis (such as Hepatitis B or C)
• Your liver condition has significantly changed in the 30 days before screening
• You have had a gastrointestinal (gut) bleed within the last month, currently have a functioning organ transplant, or have severe fluid build-up in your abdomen requiring frequent draining
• You are pregnant, breastfeeding, or have tested positive for pregnancy at screening
• You are not willing to use effective contraception during the study and for at least one month after the study treatment ends (this applies to both male and female participants)

Important: Always verify eligibility with the trial site directly before applying.