Radioactive tracer reveals how experimental drug BI 3034701 leaves the body
NCT ID NCT07708493
First seen Jul 16, 2026 · Last updated Sep 10, 2026 · Updated 5 times
Summary
This early-phase trial investigates how healthy male volunteers process and eliminate a single dose of the experimental drug BI 3034701. Eight men with normal weight or overweight will receive the drug mixed with a tiny amount of radioactive tracer, allowing researchers to track its path through urine, feces, and breath. The goal is to understand the drug's metabolism and how completely it is removed from the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called BI 3034701 mixed with a radioactive tracer
- What this could lead to
- If successful, this study will show how the body absorbs, breaks down, and gets rid of BI 3034701, which is needed before testing it as a treatment.
- What could go wrong
- This is a very early, small study in just 8 healthy men, so results may not predict how the drug works in sick people or at different doses.
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
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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.
- Started
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Aug 2026
- 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 65 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. Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests 2. Age of 18 to 65 years (inclusive) 3. Body mass index of 23.0 to 34.9 kg/m2 (inclusive) 4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice and local legislation prior to admission to the trial Exclusion criteria: 1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further exclusion criteria apply.
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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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Pharmaceutical Research Associates Magyarorszag
RECRUITINGBudapest, 1077, Hungary
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