Moderate Hepatic ImpairmentPhase 1NCT07343960
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
A Phase 1 study testing Capivasertib in people with Moderate Hepatic Impairment, run by AstraZeneca at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Hepatic Impairment
- What is being tested?
- Capivasertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jan 2026to 11 Nov 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States2 sites, 2 recruiting
- Recruiting
Research Site
Rialto, California, 92377
- Recruiting
Research Site
San Antonio, Texas, 78215
About this study
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
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).
Read the detailed description
This is a single dose, non-randomized, open-label, parallel group study. A Screening Period (Day -21 to -2): Participants in moderate impairment group will have an additional assessment of hepatic function stability on Day -7.
Treatment and Residential Period: Participants will be resident at the Investigative Site from Day -1 to Day 4 and will receive a single oral dose of capivasertib on Day 1.
Follow-up Period: Participants will return for a follow-up visit on Days 9 to 11.
- Conditions
- Moderate Hepatic Impairment
- Being tested
- Capivasertib
- Keywords
- Hepatic function, Anti-cancer agent, Pyrrolopyrimidine-derived compound, Liver metabolism, Serine/threonine protein kinase AKT, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapivasertibDrug
Also called AZD5363
Capivasertib will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Test: Capivasertib in Moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment will receive a single dose of capivasertib. Receives: Drug: Capivasertib |
| Control: Capivasertib in Normal hepatic function | Experimental | Participants with normal hepatic function will receive a single dose of capivasertib. Receives: Drug: Capivasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 4
Secondary outcomes (8)
Concentration of capivasertib in plasma over time
To compare the plasma concentration of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Measured: 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)
To compare the PK (AUC0-t) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Measured: From Day 1 to Day 4
Time to Cmax (tmax)
To compare the PK (tmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Measured: From Day 1 to Day 4
Terminal half-life (t½)
To compare the PK (t½) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Measured: From Day 1 to Day 4
Apparent plasma clearance (CL/F)
To compare the PK (CL/F) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Measured: From Day 1 to Day 4
Renal Clearance (CLR)
To compare the PK (CLR) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Measured: From Day 1 to Day 3
Apparent volume of distribution (Vz/F)
To compare the PK (Vz/F) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Measured: From Day 1 to Day 4
Number of participants with Adverse Events (AEs) and Serious AEs
To examine the safety and tolerability of a single oral dose of capivasertib in participants with moderate hepatic impairment and in those with normal hepatic function.
Measured: Up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start6 Jan 2026
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343960
- Sponsor's protocol ID
- D3615C00004
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.