Actively Recruiting
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
Led by AstraZeneca · Updated on 2026-04-09
20
Participants Needed
2
Research Sites
29 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate hepatic impairment and participants with normal hepatic function (as control).
CONDITIONS
Official Title
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight of at least 50 kg and Body Mass Index (BMI) of between 65 18 up to 64 40 kg/m2.
- Use of contraception consistent with local regulations for study participants or their partners.
- Suitable veins for cannulation or repeated venipuncture.
- Non-smoker or discontinued smoking/nicotine use at least 3 months before screening.
- Confirmed moderate hepatic impairment classified as Child Pugh class B.
- Meet National Cancer Institute - Organ Dysfunction Working Group criteria: total bilirubin 1.5 to 3 times upper limit of normal and any AST level for moderate hepatic impairment.
- Stable hepatic impairment.
- For normal hepatic function participants: bilirubin less than 1.5 times upper limit of normal, ALT, AST, albumin, ALP, GGT less than 1.2 times upper limit of normal, creatinine less than upper limit of normal, and white blood cell count above lower limit of normal.
You will not qualify if you...
- Presence of severe or uncontrolled systemic diseases like uncontrolled hypertension, significant aneurysm, renal transplant, or active bleeding.
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the drug, or significant bowel resection affecting drug absorption.
- History of primary malignancy except those treated with curative intent and no active disease for 2 or more years, excluding certain skin cancers and in situ diseases.
- Active tuberculosis infection.
- Known HIV infection, active hepatitis B or C infection, positive hepatitis C antibody, or positive hepatitis B surface antigen.
- Clinically significant abnormalities of glucose metabolism (HbA1c 65 8.0%).
- Moderate or severe renal dysfunction with creatinine clearance less than 60 mL/min.
- Fluctuating or rapidly worsening liver function.
- Hepatocellular carcinoma or acute liver disease from infection or drug toxicity.
- Severe portal hypertension or surgical porto-systemic shunts.
- Biliary obstruction or hepatic impairment from causes other than liver parenchymal disease.
- Clinically relevant hepatic encephalopathy grade 3 or higher.
- Severe ascites.
- Esophageal variceal bleeding within past 2 months unless treated with banding.
- History of liver transplantation.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Research Site
Rialto, California, United States, 92377
Actively Recruiting
2
Research Site
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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