Clinical Trials in the USA / NCT07343960
Recruiting
Phase 1
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
NCT07343960 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Moderate Hepatic Impairment
Investigational drug(s) / intervention(s)
Capivasertib: Capivasertib will be administered orally
Study 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).
Eligibility
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.
Primary outcome measure(s)
- Area under concentration time curve from zero to infinity (AUCinf) — From Day 1 to Day 4
To compare the PK (AUCinf) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. - Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) — From Day 1 to Day 4
To compare the PK (AUClast) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function. - Maximum plasma drug concentration (Cmax) — From Day 1 to Day 4
To compare the PK (Cmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Rialto | California | Recruiting |
| Research Site | San Antonio | Texas | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07343960 on ClinicalTrials.gov ↗ ← All trials in the USA