A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants with Moderate Hepatic Impairment

Study identifier:D3615C00004

ClinicalTrials.gov identifier:NCT07343960

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I, Single-dose, Non-randomized, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Capivasertib in Participants with Moderate Hepatic Impairment

Medical condition

Moderate Hepatic Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Capivasertib

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 06 Jan 2026

Estimated Primary Completion Date: 31 Jul 2026

Estimated Study Completion Date: 31 Jul 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2026 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

• Body weight of at least 50 kg and Body Mass Index (BMI) of between ≥ 18 up to ≤ 40 kg/m2.
• Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participants must have suitable veins for cannulation or repeated venipuncture.
• Non-smoker, defined as a participant who has not smoked previously or who has discontinued smoking or the use of other nicotine/nicotine-containing products at least 3 months before the Screening Visit.
• Supporting documents confirming the participant’s hepatic impairment must be available (a liver biopsy is preferable but not mandatory); participants must be classified by the Investigator as Child Pugh class B.
• Participants must meet National Cancer Institute – Organ Dysfunction Working Group (NCI-ODWG) classification of total bilirubin 1.5 to 3*upper limit of normal (ULN) and any Aspartate aminotransferase/transaminase
(AST) for moderate hepatic impairment.
• Stable hepatic impairment
• For participants with normal hepatic function, Bilirubin < 1.5 × ULN, alanine aminotransferase (ALT), AST, albumin, alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) < 1.2 × ULN. Creatinine < ULN. White blood cell count > lower limit of normal (LLN).
-

Exclusion Criteria

• Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, significant aneurysm, renal transplant and active bleeding diseases) which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
• Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib.
• History of primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
• Active tuberculosis infection.
• Known Human Immunodeficiency Virus (HIV) infection, active hepatitis B or C infection, positive hepatitis C antibody, and/or positive hepatitis B virus surface antigen.
• Clinically significant abnormalities of glucose metabolism as defined by HemoglobinA1c (HbA1c) ≥ 8.0% (63.9 mmol/mol) at screening.
• Moderate or severe renal dysfunction according to age-related creatinine clearance estimated using CKD-EPI formula (i.e., creatinine clearance less than 60 mL/min).
• Fluctuating or rapidly deteriorating hepatic function.
• Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.
• Severe portal hypertension or surgical porto-systemic shunts.
• Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
• Clinically relevant hepatic encephalopathy (Grade 3 or more).
• Severe ascites.
• Esophageal variceal bleeding (unless banded) within the past 2 months.
• Post-liver transplantation.

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Arms	Assigned Interventions
Experimental: Test: Capivasertib in Moderate hepatic impairment Participants with moderate hepatic impairment will receive a single dose of capivasertib.	Drug: Capivasertib Capivasertib will be administered orally Other Name: AZD5363
Experimental: Control: Capivasertib in Normal hepatic function Participants with normal hepatic function will receive a single dose of capivasertib.	Drug: Capivasertib Capivasertib will be administered orally Other Name: AZD5363

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]