Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects

NCT06832540 | Completed Phase 1

• 1 other identifier: TJJS01-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Mass Balance Study of \[14C\] TJ0113 in Healthy Chinese Subjects

Conditions

Healthy Chinese Subjects

Outcome Measures

Primary Outcomes (6)

• The excretion ratio of total radioactivity at each time interval and the cumulative recovery of total radioactivity in urine and feces

  The excretion ratio of total radioactivity at each time interval and the cumulative recovery of total radioactivity in urine and feces

  Predose up to 240 hours after administration of [14C]TJ0113

• Pharmacokinetic parameters of total radioactivity in plasma: Cmax

  Maximum concentration

  Predose up to 168 hours after administration of [14C]TJ0113

• Pharmacokinetic parameters of total radioactivity in plasma: Tmax

  Time to Maximum Concentration

  Predose up to 168 hours after administration of [14C]TJ0113

• Pharmacokinetic parameters of total radioactivity in plasma: t1/2

  Half Life

  Predose up to 168 hours after administration of [14C]TJ0113

• Pharmacokinetic parameters of total radioactivity in plasma: MRT

  Mean Residence Time

  Predose up to 168 hours after administration of [14C]TJ0113

• Pharmacokinetic parameters of total radioactivity in plasma: AUC

  Area Under the Plasma Concentration-time Curve

  Predose up to 168 hours after administration of [14C]TJ0113

Study Arms (1)

[14C]TJ0113

EXPERIMENTAL

A single oral dose of approximately 200 mg/100 μCi of the oral formulation of \[14C\] TJ0113

Drug: [14C]TJ0113

Interventions

[14C]TJ0113 DRUG

Subjects will receive a single oral dose of approximately 200 mg/100 μCi of the oral formulation of \[14C\] TJ0113 under fasted conditions.

[14C]TJ0113

Eligibility Criteria

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

You may qualify if:

• Healthy Chinese males;
• Age at informed consent: 18-45 years (inclusive);
• Body mass index (BMI) ranging from 19 to 26 kg/m2 (inclusive) and body weight ≥ 50 kg;
• Fully understand the objectives and requirements of this study, and voluntarily sign the informed consent form;
• Able to communicate well with study personnel and complete the study according to the protocol.

You may not qualify if:

• Auxiliary examination:
• Subjects who have abnormal and clinically significant results of comprehensive physical examination, digital anal examination, laboratory tests (hematology, blood chemistry, coagulation function, urinalysis, stool routine + occult blood, thyroid function), 12-lead ECG, ophthalmic examination (slit-lamp, intraocular pressure and fundus radiography), chest X-ray (anteroposterior) and abdominal B ultrasound (liver, gallbladder, pancreas, spleen and kidney);
• Subjects with unqualified vital signs that remain unqualified upon retesting;
• Subjects who have a resting corrected QT interval (QTcF) \> 450 ms (corrected according to Fridericia's formula) or QRS \> 120 ms as determined by 12-lead electrocardiogram (ECG), or a previous history of long QT syndrome;
• Subjects who have any clinically significant abnormality in hepatitis B surface antigen, hepatitis B E antigen, hepatitis C virus antibody (anti-HCV), treponema pallidum antibody test, and human immunodeficiency virus antibody (anti-HIV) as judged by the investigator;
• Medication History:
• Subjects who use any drug inhibiting or inducing hepatic drug-metabolizing enzyme activity (see Appendix 1 for details) within 30 days before screening;
• Subjects who use any prescription drugs, over-the-counter drugs, Chinese herbal medicines and food supplements (such as vitamins and calcium supplements) from 14 days before screening to predose;
• Disease and Surgical History:
• Subjects who have febrile illness or active infection within 14 days before screening;
• Subjects who have gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea or malabsorption syndrome, or a history of severe vomiting or diarrhea within one week before screening;
• Subjects who have a history of any clinically significant disease or any disease or condition that may affect the study results in the opinion of the investigator, including but not limited to cardiovascular system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;
• Subjects who have dysphagia or any condition that may affect oral administration and drug absorption (e.g., cholecystectomy, gastric bypass, duodenotomy, colectomy, post-gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, intestinal obstruction, etc.);
• Subjects who have undergone major surgery within 6 months before screening or have incomplete healing of surgical incision, including but not limited to any surgery with significant bleeding risk, prolonged general anesthesia, or incisional biopsy or significant traumatic injury; or who have undergone surgery affecting drug absorption, distribution, metabolism, excretion, or plan to undergo surgery during the study period;
• Subjects who have drug, environmental, food allergy or allergic constitution, or may be allergic to the investigational product judged by the investigator;

Sponsors & Collaborators

• Hangzhou PhecdaMed Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

Study Design

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

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 18, 2025
• Study Start: February 19, 2025
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)