Recruiting
Phase 1

Capivasertib

Sponsor:

AstraZeneca

Code:

NCT07343960

Conditions

Moderate Hepatic Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Capivasertib

Study Details

Brief summary:

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

Moderate Hepatic Impairment

Study ID

NCT07343960

Start date

Jan 6, 2026

Status verified date

Jun, 2026

Completion date

Nov 11, 2026

Anticipated

Primary completion date

Nov 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Key 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).

Key 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Test: Capivasertib in Moderate hepatic impairment

Participants with moderate hepatic impairment will receive a single dose of capivasertib.

experimental: Control: Capivasertib in Normal hepatic function

Participants with normal hepatic function will receive a single dose of capivasertib.

Interventions

Capivasertib

Capivasertib will be administered orally

Primary outcome measure

  • Area under concentration time curve from zero to infinity (AUCinf) [ Time Frame: From Day 1 to Day 4 ]
  • Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) [ Time Frame: From Day 1 to Day 4 ]
  • Maximum plasma drug concentration (Cmax) [ Time Frame: From Day 1 to Day 4 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Rialto, California, United States, 92377

Research Site

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

AstraZeneca

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Hepatic function
  • Anti-cancer agent
  • Pyrrolopyrimidine-derived compound
  • Liver metabolism
  • Serine/threonine protein kinase AKT
  • Pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-02.