Drug tracking study in healthy men completed

NCT ID NCT06832540

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a drug called TJ0113 is processed and removed from the body in healthy Chinese men. Six participants took a single dose, and researchers measured the drug in their blood, urine, and stool over time. The goal was to understand how the drug is eliminated, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Feb 2025

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy Chinese males; 2. Age at informed consent: 18-45 years (inclusive); 3. Body mass index (BMI) ranging from 19 to 26 kg/m2 (inclusive) and body weight ≥ 50 kg; 4. Fully understand the objectives and requirements of this study, and voluntarily sign the informed consent form; 5. Able to communicate well with study personnel and complete the study according to the protocol. Exclusion Criteria: Auxiliary examination: 1. 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); 2. Subjects with unqualified vital signs that remain unqualified upon retesting; 3. 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; 4. 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: 5. Subjects who use any drug inhibiting or inducing hepatic drug-metabolizing enzyme activity (see Appendix 1 for details) within 30 days before screening; 6. 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: 7. Subjects who have febrile illness or active infection within 14 days before screening; 8. 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; 9. 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; 10. 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.); 11. 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; 12. Subjects who have drug, environmental, food allergy or allergic constitution, or may be allergic to the investigational product judged by the investigator; 13. Subjects who have hemorrhoids or perianal diseases accompanied by regular/ongoing hematochezia, irritable bowel syndrome, inflammatory bowel disease; Life Style: 14. Habitual constipation or diarrhea; 15. Subjects who have alcoholism or regular drink within 6 months before screening, defined as drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits 40% or 150 mL of wine), or have a breathalyzer test result \> 0 mg/100 ml at screening, or unable to abstain from alcohol during the study; 16. Subjects who smoke more than 5 cigarettes per day or habitually use nicotine-containing products within 3 months before screening, or inability to abstain during the study; 17. Subjects who abuse drugs or use soft drugs (such as marijuana) 3 months before screening or take hard drugs (such as amphetamines, phencyclidine, etc.) 1 year before screening; or have positive urine drug test during screening; 18. Subjects who have special requirements for diet or fail to follow the standard diet (such as intolerant of standard meals); habitually drink grapefruit juice or excessive tea, coffee and/or caffeine beverages, or unable to abstain during the study; refuse to discontinue any beverages containing xanthine derivatives, such as caffeine (coffee, tea, cola, chocolate, etc.) from 48 hours pre-dose until the end of the study; refuse to discontinue animals' viscera, seafood, soy products and other foods containing high purine; 19. Subjects who have strenuous exercise or other factors affecting drug absorption, distribution, metabolism and excretion; 20. Lactose intolerance (subjects who have had diarrhea from drinking milk); Others: 21. Subjects who are exposed to radioactivity for a prolonged period, or have significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥ 3 other X-ray examinations) within one year before screening, or have participated in radiopharmaceutical labeling trials within one year before screening; 22. Subjects who have a history of syncope due to the needles or blood, or difficult blood collection or cannot tolerate venipuncture for blood collection; 23. Subjects who have participated in any clinical trial within 3 months before screening and have received an investigational product or used an investigational device; or those who plan to participate in other clinical trials during this study, or subjects who do not participate in the clinical trial in person; 24. Subjects who have been vaccinated within 1 month before screening or planned to receive vaccination during the study; 25. Subjects who plan to father a child or donate sperm from the time of signing the informed consent form to 1 year after completing the study, or do not agree to take strict contraceptive measures (see Appendix 3 for details) for themselves and their spouses from the time of signing the informed consent form to 1 year after completing the study; 26. Subjects who have blood loss or blood donation ≥ 400 mL within 3 months before screening, or blood transfusion or blood component within 1 month before screening, or blood donor during planned medication and within 3 months after discontinuation; 27. Subjects who have any other factor that the investigator considers inappropriate for participation in this study or the subject withdraws from the study for his/her own reasons.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy chinese subjects are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, China