Phase
Condition
Primary Biliary Cholangitis
Treatment
AZD5004
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For ALL participants:
Adults 18-80 years of age
Weight ≥50kg and BMI between ≥18 to ≤40 kg/m2 For participants with normal hepaticfunction:
Participant must be stable on a concomitant medication and/or treatment regimen forat least 2 weeks prior to screening
For Healthy Controls:
-Participant must be medically healthy with no significant findings on medical evaluation at screening to include but not limited to an eGFR >90 ml/min/1.73 m2
For participants with hepatic impairment:
- Group 1 (mild) must have an Child-Pugh score of 5 or 6, Group 2 (moderate) must havea Child-Pugh score of 7 to 9, Group 3 (severe) must have a Child-Pugh score of 10 to
- Participant must have a diagnosis of chronic (≥ 6 months) and stable hepaticimpairment (eg, no clinically significant change in signs, symptoms, or laboratoryparameters of hepatic disease status within 30 days prior to study screening
Exclusion
Exclusion Criteria:
For ALL participants:
Poorly controlled diabetes mellitus (A1C >10% at screening).
Unwillingness to use adequate contraception
Uncontrolled hypertension or hypotension
Presence of unstable systemic disease or psychologic conditions.
Any clinically significant abnormalities in rhythm, conduction, or morphology of theresting ECG and any clinically important abnormalities in the 12-lead ECG.
Specific For Healthy Controls:
-Positive screening for HIV, Hepatitis B, or Hepatitis C -
-Any clinically significant disease or disorder to include but not limited to acute or chronic liver disease
Specific For Hepatically Impaired Participants:
eGFR <60 ml/min/1.73 m2
Fluctuating or rapidly deteriorating hepatic function, as indicated by stronglyvarying or worsening of clinical and/or laboratory signs of hepatic impairment toinclude rising LFTs, paracentesis at less than 4 week intervals, oesophageal bandingwithin the last 3 months, or treatment for GI bleeding within the last 6 months
Presence of a hepatocellular carcinoma or acute liver disease caused by an infectionor drug toxicity.
Study Design
Study Description
Connect with a study center
Research Site
Lake Forest, California 92630
United StatesActive - Recruiting
Research Site
Rialto, California 92377
United StatesActive - Recruiting
Research Site
Orlando, Florida 32809
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78215
United StatesActive - Recruiting
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