Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function

NCT05048368 | Not Yet Recruiting Phase 1

• 1 other identifier: Z650-HI-105
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Esophageal Cancer; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration of study drugs

  Day 1 to Day 7

• 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

  Day 1 to Day 7

Secondary Outcomes (1)

• Adverse Event

  Day-7 to Day 14

Study Arms (4)

Cohort A-Larotinib

EXPERIMENTAL

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

Drug: Larotinib

Cohort B-Larotinib

EXPERIMENTAL

Subjects with mild hepatic impairment

Drug: Larotinib

Cohort C-Larotinib

EXPERIMENTAL

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

Drug: Larotinib

Cohort D-Larotinib

EXPERIMENTAL

Subjects with moderate hepatic impairment.

Drug: Larotinib

Interventions

Larotinib DRUG

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

Cohort A-Larotinib; Cohort B-Larotinib; Cohort C-Larotinib; Cohort D-Larotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects with normal hepatic function (cohorts A and C) :
• \. Sign the informed consent form before the trial；
• \. 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);
• Must be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening；
• 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) :
• \. Sign the informed consent form before the trial.
• \. 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；
• \. 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
• \. 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.
• \. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.

You may not qualify if:

• ALL subjects
• \. The subject has been diagnosed with acquired immune deficiency syndrome (AIDS), or tests positive for human immunodeficiency virus (HIV).
• \. Currently suffering from any bleeding disease, such as gastric and duodenal ulcer
• \. Those who had undergone major surgery within 6 months before the screening period or the surgical incision did not completely heal;
• \. History of hand foot syndrome;
• \. Those who have a history of liver cancer or other malignant tumors before signing the informed consent
• \. 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
• \. Take any food or beverage products containing alcohol, caffeine, xanthine and grapefruit within 48 hours prior to the first dose.
• \. The subject has received blood within 1 month, or donated loss of blood over 400 mL within 3 months prior to the screening
• \. Have a history of alcoholism or positive alcohol breath test during the screening period;
• \. Those who smoke more than 5 cigarettes a day or habitually use nicotine containing products 3 months before screening
• \. 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
• \. Allergic constitution
• \. Within 28 days before screening, inhibitors or inducers of CYP3A4, cyp2c8, CYP2C19 and P-gp were used
• \. Participated in any other intervention clinical trial within 3 months before screening

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jia Miao, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Miao, MD

CONTACT

+86 18980601806; miaosiyi1971@163.com

Hong Tang, MD

CONTACT

+86 18980601313; Htang6198@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 17, 2021
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CN (1)