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Early drug study aims to understand BI 1839100's journey in the body

NCT ID NCT06572111

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial in 8 healthy men aims to understand how the experimental drug BI 1839100 is processed by the body. Part A tracks the drug and its radioactive label in urine and feces after an oral dose. Part B compares how much of the drug reaches the bloodstream when given orally versus intravenously. The study is terminated, so results may be limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 1839100

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

8 people

The number who actually took part.

Started

Sep 2024

Finished

Sep 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 59 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 male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electronic cardiogram (ECG), and clinical laboratory tests. 2. Age of 18 to 59 years (inclusive at screening) 3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive at screening) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Exclusion Criteria: 1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or ECG that deviates from normal and is assessed as clinically significant by the investigator 2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm (subjects with PR values between 45 and 50 bpm may only be enrolled in case they have normal thyroid function (thyroid-stimulating hormone (TSH) and free thyroxine (FT4) at baseline-screening, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical significance 4. Any evidence of a concomitant disease assessed as clinically significant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically significant by the investigator 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the Pharmacokinetics (PKs) of the trial medication (except appendectomy or simple hernia repair) 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders assessed as clinically relevant by the investigator 8. History of significant orthostatic hypotension, fainting spells, or blackouts 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.

Contacts and locations

Locations

  • ICON-Groningen-62040

    Groningen, 9728 NZ, Netherlands

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