HealthyPhase 1NCT07065617
A Study to Test How BI 1819479 is Taken up and Processed by the Body
A Phase 1 study testing [14C]BI 1819479, BI 1819479 and BI 1819479 (C-14) in people with Healthy, run by Boehringer Ingelheim at 1 site in United Kingdom.
Trial summary
This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]BI 1819479, BI 1819479 and BI 1819479 (C-14)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2025to 4 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants 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 electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
- Age of 18 to 55 years (inclusive)
- Body Mass Index (BMI) of 18.5 to 32.0 kg/m^2 (inclusive)
- Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day), applicable to Part A only
Who cannot join
- Any finding in the medical examination (including vital signs or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mm Hg, or heart rate outside the range of 45 to 90 bpm (beats per minute)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, assessed as clinically relevant by the investigator
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Two-part Trial to Investigate the Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 1819479 (C-14) Administered as an Oral Solution (Part A) and to Investigate the Absolute Bioavailability of BI 1819479 Administered as a Film-coated Tablet Together With an Intravenous Microtracer Dose of [14 C]BI 1819479 (Part B) in Healthy Male Volunteers
This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- [14C]BI 1819479, BI 1819479, BI 1819479 (C-14)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]BI 1819479Drug
[14C]BI 1819479
BI 1819479Drug
BI 1819479
BI 1819479 (C-14)Drug
BI 1819479 mixed with [14C]BI 1819479
| Study group | Role | What they receive |
|---|---|---|
| Part A: BI 1819479 (C-14) | Experimental | Not described Receives: Drug: BI 1819479 (C-14) |
| Part B: BI 1819479, then [14C]BI 1819479 | Experimental | Not described Receives: Drug: [14C]BI 1819479; Drug: BI 1819479 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine, 0-tz)
Measured: Up to 37 days.
Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces, 0-tz)
Measured: Up to 37 days.
Part B: area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 31 days.
Secondary outcomes (6)
Part A: Maximum measured concentration of [14C]BI 1819479-EQ in plasma (Cmax)
Measured: Up to 36 days.
Part A: Area under the concentration-time curve of [14C]BI 1819479-EQ in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Measured: Up to 36 days.
Part B: Maximum measured concentration of [14C]BI 1819479 in plasma (Cmax)
Measured: Up to 31 days.
Part B: Maximum measured concentration of BI 1819479 in plasma (Cmax)
Measured: Up to 31 days.
Part B: Area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Measured: Up to 31 days.
Part B: Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Measured: Up to 31 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start4 Aug 2025
- Primary completion4 Oct 2025
- Study completion4 Nov 2025
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part A is a single arm trial whereas Part B is conducted in a fixed-sequence.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065617
- Sponsor's protocol ID
- 1462-0007
- Status last verified
- Sep 2026
- First submitted
- 4 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Two-part Trial to Investigate the Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 1819479 (C-14) Administered as an Oral Solution (Part A) and to Investigate the Absolute Bioavailability of BI 1819479 Administered as a Film-coated Tablet Together With an Intravenous Microtracer Dose of [14 C]BI 1819479 (Part B) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT07065617
- Acronym / sponsor ID
- 1462-0007
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A is a single arm trial whereas Part B is conducted in a fixed-sequence.
| Arm | Type | Receives |
|---|---|---|
| Part A: BI 1819479 (C-14) | Experimental | Drug: BI 1819479 (C-14) |
| Part B: BI 1819479, then [14C]BI 1819479 | Experimental | Drug: [14C]BI 1819479, Drug: BI 1819479 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male participants 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 electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
- Age of 18 to 55 years (inclusive)
- Body Mass Index (BMI) of 18.5 to 32.0 kg/m^2 (inclusive)
- Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day), applicable to Part A only
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including vital signs or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mm Hg, or heart rate outside the range of 45 to 90 bpm (beats per minute)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, assessed as clinically relevant by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]BI 1819479[14C]BI 1819479 | Drug | Part B: BI 1819479, then [14C]BI 1819479 |
| BI 1819479BI 1819479 | Drug | Part B: BI 1819479, then [14C]BI 1819479 |
| BI 1819479 (C-14)BI 1819479 mixed with [14C]BI 1819479 | Drug | Part A: BI 1819479 (C-14) |
Primary outcome
Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine, 0-tz)
Time frame: Up to 37 days.
Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces, 0-tz)
Time frame: Up to 37 days.
Part B: area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 31 days.
6 secondary outcomes
Part A: Maximum measured concentration of [14C]BI 1819479-EQ in plasma (Cmax)
Time frame: Up to 36 days.
Part A: Area under the concentration-time curve of [14C]BI 1819479-EQ in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Time frame: Up to 36 days.
Part B: Maximum measured concentration of [14C]BI 1819479 in plasma (Cmax)
Time frame: Up to 31 days.
Part B: Maximum measured concentration of BI 1819479 in plasma (Cmax)
Time frame: Up to 31 days.
Part B: Area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Time frame: Up to 31 days.
Part B: Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Time frame: Up to 31 days.
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]BI 1819479, BI 1819479 and BI 1819479 (C-14) in people with Healthy, run by Boehringer Ingelheim at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine, 0-tz) (time frame: Up to 37 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.