Liver health may change how cancer drug works
NCT ID NCT05048368
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial investigates how the body handles larotinib, an experimental cancer drug, in people with mild or moderate liver impairment compared to healthy volunteers. Participants receive a single oral dose, and researchers measure drug levels in the blood over time. The goal is to understand if liver function affects drug exposure, which could guide dosing for patients with liver issues.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- larotinib
- What this could lead to
- If successful, this study could help determine the right dose of larotinib for patients with liver problems, potentially making the drug safer and more effective for them.
- What could go wrong
- This is an early-stage, small study focused on drug processing, not on treating cancer. Results may not predict real-world outcomes, and liver impairment could alter drug safety in unexpected ways.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * healthy subjects with normal hepatic function (cohorts A and C) : * 1\. Sign the informed consent form before the trial; * 2\. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight \>50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg/m\^2, (including critical value) \[BMI= weight (kg)/height\^2 (m\^2)\] (BMI matching ±15% with liver dysfunction cohort); * 3.Must be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening; * 4.Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures. * Subjects with mild/ Moderate hepatic Impairment (cohorts B and D) : * 1\. Sign the informed consent form before the trial. * 2\. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight \>50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg/m\^2; * 3\. Must satisfy the criteria for hepatic Impairment as evidenced by a Child-Pugh class of A or B at Screening:Class A; Mild; Child-Pugh score 5-6;Class B; Moderate; Child-Pugh score 7-9 * 4\. The liver function status of the subjects was determined to be stable between 1 month before taking the experimental drug and the end of the study, with no significant change. * 5\. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures. Exclusion Criteria: * ALL subjects * 1\. The subject has been diagnosed with acquired immune deficiency syndrome (AIDS), or tests positive for human immunodeficiency virus (HIV). * 2\. Currently suffering from any bleeding disease, such as gastric and duodenal ulcer * 3\. Those who had undergone major surgery within 6 months before the screening period or the surgical incision did not completely heal; * 4\. History of hand foot syndrome; * 5\. Those who have a history of liver cancer or other malignant tumors before signing the informed consent * 6\. Those who have a history of gastrointestinal and renal diseases or surgery that may affect drug absorption, distribution, metabolism and excretion within 6 months before screening, or have diseases that can reduce compliance * 7\. Take any food or beverage products containing alcohol, caffeine, xanthine and grapefruit within 48 hours prior to the first dose. * 8\. The subject has received blood within 1 month, or donated loss of blood over 400 mL within 3 months prior to the screening * 9\. Have a history of alcoholism or positive alcohol breath test during the screening period; * 10\. Those who smoke more than 5 cigarettes a day or habitually use nicotine containing products 3 months before screening * 11\. Those who had a history of drug abuse or used drugs within 2 years before screening or those who were positive for urinary drug screening during the screening period Allergic constitution * 12\. Allergic constitution * 13\. Within 28 days before screening, inhibitors or inducers of CYP3A4, cyp2c8, CYP2C19 and P-gp were used * 14\. Participated in any other intervention clinical trial within 3 months before screening * 15\. Female subjects with positive pregnancy test results or breastfeeding during screening; * 16\. Any other circumstances that the investigator considers unsuitable for participation in this study * The following exclusion criteria apply only to healthy subjects with normal hepatic function (cohorts A and C) : * 17\. he subject has evidence of clinically significant cardiovascular, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities. * 18\. The subject tests positive for HBsAg or Hepatitis C antibody * 19\. The subject has used any prescription or nonprescription drugs within 2 weeks prior to the screening. * The following exclusion criteria apply only to subjects with mild/ Moderate hepatic Impairment (cohorts B and D) : * 17\. The following exclusion criteria apply only to subjects with liver function impairment (cohorts B and D) : * a) ALT\>10×ULN; * b) AST\> 10×ULN; * c) Absolute count of neutrophils \<0.75×10\^9/L; * d) PLT\<50×10\^9/L * e) HGB\<60 g/L * f) AFP \>100 ng/mL; If 20 ng/mL≤AFP≤100 ng/mL, liver MRI are required to exclude subjects with suspected HCC. * g) eGFR\<60 mL/min/1.73m\^2. * h) Male:QTcF\> 450 msec,Female:QTcF\>470 msec。 * 18\. The subject has any of the following conditions: Diseases affecting bile excretion such as biliary obstruction; Drug induced liver injury; History of liver transplantation; Liver failure, or liver cirrhosis patients with complications such as hepatic encephalopathy, rupture and bleeding of esophageal and gastric varices, etc; Patients with severe or advanced peritoneal effusion or pleural effusion need puncture drainage and albumin supplementation. Patients with hepatorenal syndrome. * 19\. Previous severe esophagogastric varices or previous portosystemic shunt, including transjugular intrahepatic portosystemic shunt (TIPS) * 20\. Cardiovascular events occurred within 6 months before screening * 21\. Those who use prescription drugs, over-the-counter drugs, Chinese herbal medicine or food supplements other than drugs for the treatment of liver function impairment and other accompanying diseases within 14 days before screening; * 22\. Medical conditions which are not adequately and stably controlled on stable doses of medications or which, in the clinical opinion of the Principal Investigator, may interfere with study procedures or participant safety.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
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