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

NCT07343960 | Recruiting Phase 1 FDA Drug

• 1 other identifier: D3615C00004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Area under concentration time curve from zero to infinity (AUCinf)

  To compare the PK (AUCinf) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.

  From Day 1 to Day 4

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  To compare the PK (AUClast) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.

  From Day 1 to Day 4

• Maximum plasma drug concentration (Cmax)

  To compare the PK (Cmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.

  From Day 1 to Day 4

Secondary Outcomes (8)

• Concentration of capivasertib in plasma over time

  From Day 1 to Day 4

• Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-t)

  From Day 1 to Day 4

• Time to Cmax (tmax)

  From Day 1 to Day 4

• Terminal half-life (t½)

  From Day 1 to Day 4

• Apparent plasma clearance (CL/F)

  From Day 1 to Day 4

Study Arms (2)

Test: Capivasertib in Moderate hepatic impairment

EXPERIMENTAL

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

Drug: Capivasertib

Control: Capivasertib in Normal hepatic function

EXPERIMENTAL

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

Drug: Capivasertib

Interventions

Capivasertib DRUG

Capivasertib will be administered orally

Also known as: AZD5363

Control: Capivasertib in Normal hepatic function; Test: Capivasertib in Moderate hepatic impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (2)

Research Site

Rialto, California, 92377, United States

RECRUITING

Research Site

San Antonio, Texas, 78215, United States

RECRUITING

MeSH Terms

Interventions

capivasertib

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (2)