ClinicalTrials.gg
WithdrawnNCT05048368Updated Sep 28, 2026

Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function

A Phase 1 interventional study of Larotinib in Esophageal Cancer and Advanced Solid Tumor, sponsored by Sunshine Lake Pharma Co., Ltd.. Withdrawn at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Study was withdrawn per sponsor decision after recruitment opened with no participants enrolled.
Updated Sep 28, 2026Now WithdrawnEnrollment updatedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration

Read the detailed description

A phase I, a single-center, non-randomized, open, single-dose administration study to explore the safety, pharmacokinetics of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects with normal hepatic function.

This study is divided into four cohorts, cohort A and cohort C in healthy subjects, cohort B for mild hepatic function impairment participants, cohort D for moderate hepatic function impairment, participants in cohort A and cohort B, group C and group D should be matched in terms of sex, age, and body mass index (BMI). A total of 32 subjects, 8 in each cohort, both male and female, are planned to be enrolled. If a complete PK blood sample is not collected due to subjects' early withdrawal from the study, new subjects will be enrolled to meet the pharmacokinetic parameters that can be evaluated for each cohort of 8 subjects.

02

Conditions studied

  • Esophageal Cancer
  • Advanced Solid Tumor
03

In context

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

Browse Esophageal Neoplasms studies →

Lead sponsor

Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 83 studies on the registry; 13 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy subjects with normal hepatic function (cohorts A and C) :
  • 1. Sign the 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. () : 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, , 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 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 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

Exclusion Criteria:

  • ALL subjects
  • 1. The subject has been diagnosed with acquired immune deficiency syndrome (AIDS), or tests positive for (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
  • 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 , 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 cardiovascular, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities.
  • 18. The subject tests positive for or 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) >10×;
  • b) AST> 10×ULN;
  • c) Absolute count of neutrophils \<0.75×10\^9/L;
  • d) \<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) \<60 mL/min/1.73m\^2.
  • h) Male:> 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.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cohort A-Larotinib

    Cohort A:Healthy participants with normal hepatic function (match to subjects with mild hepatic impairment\_cohort B)

    Drug: Larotinib

  • Experimental
    Cohort B-Larotinib

    Subjects with mild hepatic impairment

    Drug: Larotinib

  • Experimental
    Cohort C-Larotinib

    Healthy participants with normal hepatic function (match to subjects with moderate hepatic impairment\_cohort D)

    Drug: Larotinib

  • Experimental
    Cohort D-Larotinib

    Subjects with moderate hepatic impairment.

    Drug: Larotinib

Interventions

  • Capsules, Oral, 350 mg, single dose, one day

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum plasma concentration of study drugs

    Time frame: Day 1 to Day 7

  2. Area Under Curve From 0 to Infinity (AUC0-infinity)

    AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

    Time frame: Day 1 to Day 7

Secondary outcomes

  1. Adverse Event

    New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

    Time frame: Day-7 to Day 14

07

Study locations

1 site
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2021
First posted
Sep 17, 2021
StartEst.
Oct 30, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Withdrawn Study was withdrawn per sponsor decision after recruitment opened with no participants enrolled.
changed Sep 28, 2026
Enrollment
32 (estimated)→0 (actual)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Withdrawn
    Why stopped Study was withdrawn per sponsor decision after recruitment opened with no participants enrolled.
    Enrollment 32 (estimated)→0 (actual)
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05048368
Responsible party
Sponsor
First posted
Sep 17, 2021
Start date
Oct 30, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 28, 2026

Study contacts

Jia Miao, MD
principal investigator · West China Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Larotinib Mesylate

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