Healthy men help unravel how liver fibrosis drug leaves the body
NCT ID NCT07471217
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time
Summary
This study looks at how the drug Hydronidone is absorbed, broken down, and removed from the body. Eight healthy Chinese men will take a single dose with a radioactive tracer so researchers can measure the drug in blood, urine, and stool. The goal is to understand the drug's journey in the body, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Apr 2026
- Finished
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May 2026
- Lead sponsor
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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
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18 to 50 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form; * Chinese adult male participants aged 18 to 50 years (inclusive); * Participants weighing at least 50 kg at screening, with a body mass index \[BMI = weight (kg) / height² (m²)\] within the range of 19.0 to 26.0 kg/m² (inclusive); * Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner. Exclusion Criteria: * The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system; * Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant; * Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant; * Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody; * Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except for appendectomy), or plans to undergo surgery during the trial period; * A previous diagnosis of Gilbert's syndrome; * Hemorrhoids with bloody stools or perianal diseases with regular or ongoing bloody stools; severe nausea or vomiting within one week before screening; habitual constipation or diarrhea; or positive fecal occult blood test; * Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days or 5 half-lives (whichever is longer) prior to dosing; use of strong inhibitors or inducers of UGTs, SULTs, CYP3A4, P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1/3, or any drugs known to prolong the QT/QTc interval or carry a risk of causing torsade de pointes (TdP) within 4 weeks before screening (see Appendix 2 for details); or plans to use any chemical drugs, biologics, traditional Chinese medicines, or natural products during the trial that the researcher deems unsuitable; * A history of drug allergies or allergic diseases (such as asthma, urticaria, eczematous dermatitis), or a suspected or confirmed allergy to the trial drug (including similar drugs) or any of its excipients as determined by the researcher; * Participants with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; * Participation in any other clinical trial drug or interventional clinical study within 3 months before screening; * Blood donation or blood loss ≥ 400 mL within 3 months before dosing, or blood transfusion or use of blood products within 4 weeks before dosing; * Difficulty in blood collection or intolerance to venous blood sampling. * Individuals who work with long-term exposure to radioactive conditions, or those with significant radioactive exposure within 1 year prior to screening (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations), or those who have participated in radiolabeled drug trials within 1 year prior to screening; * History of drug abuse or substance abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine); * Average weekly alcohol consumption of ≥14 units within 3 months prior to screening (1 unit ≈ 360 mL beer, or 45 mL liquor, or 150 mL wine), or positive breath alcohol test; * Average daily smoking of \>5 cigarettes (or equivalent nicotine products) within 3 months prior to dosing, or inability to discontinue any tobacco products during the study, or positive cotinine test; * Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL), and inability to abstain during the study; or consumption of any chocolate, caffeine, or xanthine-rich foods or beverages within 48 hours prior to dosing; * Vaccination within 4 weeks prior to dosing, or planned vaccination within 1 month after dosing; * Other reasons deemed by the investigator as making the participant unsuitable for this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Gaobo Hospital
Beijing, Beijing Municipality, 100000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.