Radioactive tag reveals Drug's exit route in tiny trial
NCT ID NCT07460284
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study gives 8 healthy men a single shot of a drug tagged with a radioactive tracer to see how it leaves the body through urine and stool. The goal is purely to understand the drug's breakdown and elimination, not to treat any disease. Participants must be healthy adults aged 18-55 with a BMI between 20 and 35.
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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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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- 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 55 years
- Sex
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Anyone
- 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. Participants who sign the informed consent form, fully understand the content, process, and possible adverse reactions of the study, and are able to complete the study as required by the study protocol; 2. Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF); 3. Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)/height2 (m 2) between 20.0-35.0 kg/m2 (inclusive); 4. Participants (including partners) who agree to voluntarily use effective contraception from screening until 6 months after the investigational drug administration and have no sperm donation plan. For specific contraceptive measures Exclusion Criteria: 1. Subjects with trauma, surgical scar, or skin lesions at the proposed administration site (abdomen) who are not suitable for subcutaneous injection as assessed by the investigator; 2. History of hypoglycemic episodes within 12 months prior to screening; 3. Major surgery or serious infection within 12 weeks prior to screening; 4. Acute disease from the signing of the ICF to the administration of the investigational drug; 5. Smoking more than 5 cigarettes per day within 12 weeks prior to screening, or unable to abstain from smoking within 7 days prior to admission and during the study; 6. Participants who are not otherwise eligible to participate in this study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
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