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AzTrials

Esophageal CancerPhase 1NCT05048368

Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function

A Phase 1 study testing Larotinib in people with Esophageal Cancer and Advanced Solid Tumor, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Esophageal Cancer, Advanced Solid Tumor
What is being tested?
Larotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
30 Oct 2026to 30 Dec 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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) :
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: A Pharmacokinetic Study of Larotinib in Subjects With Mild/Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

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.

Being tested
Larotinib
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LarotinibDrug

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

Study groups in NCT05048368
Study groupRoleWhat they receive
Cohort A-LarotinibExperimentalCohort A:Healthy participants with normal hepatic function （match to subjects with mild hepatic impairment_cohort B）
Receives: Drug: Larotinib
Cohort B-LarotinibExperimentalSubjects with mild hepatic impairment
Receives: Drug: Larotinib
Cohort C-LarotinibExperimentalHealthy participants with normal hepatic function （match to subjects with moderate hepatic impairment_cohort D）
Receives: Drug: Larotinib
Cohort D-LarotinibExperimentalSubjects with moderate hepatic impairment.
Receives: Drug: Larotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Maximum plasma concentration of study drugs

    Measured: 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

    Measured: Day 1 to Day 7

Secondary outcomes (1)

  1. Adverse Event

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

    Measured: Day-7 to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Why it stopped: Study was withdrawn per sponsor decision after recruitment opened with no participants enrolled.

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study is divided into four cohorts: healthy subjects in cohort A and C, mild liver function impairment subjects in cohort B, and moderateliver function impairment subjects in cohort D. Cohorts A and B, C and D should be matched in terms of gender, age, and body mass index (BMI).
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048368
Sponsor's protocol ID
Z650-HI-105
Status last verified
Aug 2026
First submitted
6 Sep 2021
Last updated
28 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Larotinib in people with Esophageal Cancer and Advanced Solid Tumor, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Day 1 to Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05048368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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