Healthy men needed to track Drug's path out of the body
NCT ID NCT07612306
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times
Summary
This early-stage study looks at how a drug called Flonoltinib maleate (being developed for a bone marrow condition) is processed and removed from the body. Six healthy adult men will take a single dose, and researchers will measure the drug and its breakdown products in blood, urine, and stool. The goal is to understand excretion routes and safety, 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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Jul 2026
- Finished
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Jul 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 45 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: 1. Chinese healthy adult male, aged 18-45 years old 2. Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m\^2 3. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements. Exclusion Criteria: 1. Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR \^ 0.33)) corrected QT interval (QTcF)\>450 milliseconds 2. HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test 3. Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results 4. Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in, and have engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. Or those who are unable to stop eating any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) during the trial period, and cannot avoid vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc 5. Engaged in workers who require long-term exposure to radioactive conditions, or have significant radiation exposure (\>=2 chest/abdominal CT scans, or \>= 3 other types of X-ray examinations) within 1 year before administration, or have participated in radiopharmaceutical labeling tests within 1 year 6. Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection
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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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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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