ADME Study of [14C]- Larotinib in Healthy Male Subjects

NCT05059743 | Completed Phase 1

• 1 other identifier: Z650-HV-106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate the Mass Balance and Biotransformation of Single Dose \[14C\]-Larotinib（Z650）in healthy male subjects.

Conditions

Healthy Adult Male Volunteers

Outcome Measures

Primary Outcomes (2)

• Cumulative excretion of 14C-labeled drug-related material (radioactivity in plasma, urine and fecal samples)

  Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.

  up to 15 days

• Identification of the Proportion of different metabolites to determine biotransformation pathway of Larotinib

  Proportion of different metabolites(Larotinib and main metabolites） .

  up to 15 days

Secondary Outcomes (2)

• Quantitive analysis of the concentrations of Larotinib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data

  up to 15 days

• Adverse events

  up to 22 days

Study Arms (1)

[14C]-Larotinib

EXPERIMENTAL

Patients will receive single dose of \[14C\]-Larotinib (Suspension, 350mg/100μCi).

Drug: [14C]-Larotinib

Interventions

[14C]-Larotinib DRUG

Patients will receive single dose of orally \[14C\]-Larotinib on Day 1.

[14C]-Larotinib

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males, 18 to 45 years at the time of screening.
• Weight\>50 kg, Body mass index (BMI) is 19\~26 kg/m2
• signing of informed consent
• Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process

You may not qualify if:

• physical examination, vital signs, routine laboratory tests 12-lead ECG, Chest X-ray ,ophthalmologic examination, abdominal B-ultrasound and other abnormalities and clinical significance.
• positive testing for HIV, HBsAg, HBeAb, HCVAb or Syphilis antibody.
• C- reactive protein (CRP) abnormalities are clinically significant or New Coronavirus nucleic acid positive.
• Screening for use of any clinical trial drug within the first 3 months or withdrawal time shorter than the 7 half-life period of the trial drug at enrollment, whichever is the longest of the two;
• CYP3A4, CYP2C8 , CYP2C9 and p-gp inducers or inhibitors were taken within 28 days before screening
• Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening;
• clinical symptoms or diseases of the heart;supraventral or ventricular arrhythmia with clinical significance that requires treatment or intervention; QTcF\>450ms at screening stage
• Patients who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period;Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury;
• Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before screening
• Screening for abdominal fistula, gastrointestinal perforation or abdominal abscess in the first 6 months;
• Hemorrhoids or perianal diseases with regular/bleeding in the stool;Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers;
• Allergic persons,
• A history of any clinically serious illness or condition, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and metabolic diseases, that the investigator considers to be likely to affect the results of the study;
• Habitual constipation or diarrhea;
• Heavy drinking or regular drinking in the six months preceding the screening period

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Study Officials

• liyan Miao, MD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 28, 2021
• Study Start: November 20, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: March 21, 2023

Record last verified: 2021-09

Locations

CN (1)