HealthyPhase 1NCT03654170

A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body

A Phase 1 study testing BI 425809 mixed with [C-14] BI425809 in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial intends to investigate the basic pharmacokinetics of BI 425809 and [14C]- radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 25 mg BI 425809 (C-14) given to healthy male subjects Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 425809 mixed with [C-14] BI425809
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteNetherlands
Study dates: 11 Sep 2018to 12 Nov 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 65 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication.
Subjects are required to use condoms to prevent unintended exposure of the partner to the study drug via seminal fluid. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above.

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Clinically significant gastrointestinal, hepatic, renal, respiratory (including but not limited to interstitial lung disease), cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 22Show fewer

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
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation). Use of CYP3A4 inhibitors and inducers 1 week prior to administration of trial medication
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
Smoker (more than 5 cigarettes or 1 cigars or 1 pipes per day)
Inability to refrain from smoking on trial days
Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 ml of spirits)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within 4 days prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

ICON
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: Metabolism and Pharmacokinetics of BI 425809 After Administration of BI 425809 (C-14) as Oral Solution in Healthy Male Volunteers

Conditions: Healthy
Being tested: BI 425809 mixed with [C-14] BI425809

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 425809 mixed with [C-14] BI425809Drug
Also called Iclepertin
Single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled [14C] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent.

Study groups in NCT03654170
Study group	Role	What they receive
BI 425809 XX (C-14)	Experimental	Participants were administered single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled [14C] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent, with 240 mL of water after an overnight fast of at least 10 hours (h). Receives: Drug: BI 425809 mixed with [C-14] BI425809

What is being measured

The primary outcome is the main question the study is designed to answer.

Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-t2)
feurine, 0-t2, fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to t2, where t2 is the last quantifiable data point across all participants mass balance recovery of total [14C]-radioactivity in urine.
Measured: PKurine samples were collected within 2 hours predose and within 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.
Mass Balance Recovery of Total [14C]-Radioactivity in Faeces (Fefaeces, 0-t2)
fefaeces, 0-t2, fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to t2, where t2 is the last quantifiable data point across all participants mass balance recovery of total [14C]-radioactivity in faeces.
Measured: PKfaeces samples were collected within 2 hours predose and within 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.

Secondary outcomes (2)

Maximum Measured Concentration of the [14C]-Radioactivity and BI 425809 (Cmax)
Maximum measured concentration of the [14C]-radioactivity and BI 425809 (Cmax).
Measured: PK samples were collected at 2 hours prior to drug administration and at 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 485, 653 hours after drug administration.
Area Under the Concentration-time Curve of the [14C]-Radioactivity and BI 425809 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)
Area under the concentration-time curve of the [14C]-radioactivity and BI 425809 over the time interval from 0 to the last quantifiable time point (AUC0-tz). For [14C]-radioactivity the latest tz was 653 h whereas for BI 425809 the latest tz was 336 h.
Measured: PK samples were collected at 2 hours prior to drug administration and at 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 485, 653 hours after drug administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201812 Nov 2018

First posted31 Aug 2018
Study start11 Sep 2018
Primary completion12 Nov 2018
Study completion12 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03654170
Sponsor's protocol ID: 1346-0016
Other IDs: 2018-001192-21, 2018
Status last verified: Feb 2026
First submitted: 29 Aug 2018
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Publications

Burkard U, Desch M, Shatillo Y, Wunderlich G, Mack SR, Schlecker C, Teitelbaum AM, Liu P, Chan TS. The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [14C]-BI 425809 in Healthy Males. Clin Drug Investig. 2022 Jan;42(1):87-99. doi: 10.1007/s40261-021-01111-9. Epub 2021 Dec 22.
PubMed 34936055

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metabolism and Pharmacokinetics of BI 425809 After Administration of BI 425809 (C-14) as Oral Solution in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT03654170
Acronym / sponsor ID: 1346-0016
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 11 Sep 2018 (actual)
Primary completion: 12 Nov 2018 (actual)
Study completion: 12 Nov 2018 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 425809 XX (C-14)	Experimental	Drug: BI 425809 mixed with [C-14] BI425809Participants were administered single oral dose of 25 milligram (mg) mixture of Carbon 14 labelled [14C] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent, with 240 mL of water after an overnight fast of at least 10 hours (h).

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 65 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication.

Key exclusion criteria (22 listed)

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Clinically significant gastrointestinal, hepatic, renal, respiratory (including but not limited to interstitial lung disease), cardiovascular, metabolic, immunological or hormonal disorders

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
BI 425809 mixed with [C-14] BI425809Also: IclepertinSingle oral dose of 25 milligram (mg) mixture of Carbon 14 labelled [14C] BI 425809 XX, containing a radioactive dose of 3.7 MegaBecquerel (MBq), and unlabeled BI 425809 XX dissolved in 12.5 milliliter (mL) polyethylene glycol 400 (PEG) as solvent.	Drug	BI 425809 XX (C-14)

Primary outcome

Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-t2)
Time frame: PKurine samples were collected within 2 hours predose and within 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.
feurine, 0-t2, fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to t2, where t2 is the last quantifiable data point across all participants mass balance recovery of total [14C]-radioactivity in urine.
Mass Balance Recovery of Total [14C]-Radioactivity in Faeces (Fefaeces, 0-t2)
Time frame: PKfaeces samples were collected within 2 hours predose and within 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.
fefaeces, 0-t2, fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to t2, where t2 is the last quantifiable data point across all participants mass balance recovery of total [14C]-radioactivity in faeces.

2 secondary outcomes

Maximum Measured Concentration of the [14C]-Radioactivity and BI 425809 (Cmax)
Time frame: PK samples were collected at 2 hours prior to drug administration and at 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 485, 653 hours after drug administration.
Area Under the Concentration-time Curve of the [14C]-Radioactivity and BI 425809 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)
Time frame: PK samples were collected at 2 hours prior to drug administration and at 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 485, 653 hours after drug administration.

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 425809 XX (C-14)	6	6

Primary outcome: Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-t2)

Time frame: PKurine samples were collected within 2 hours predose and within 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of dose excreted (%)

Measure	[14C] BI 425809 n = 6
Value	48.1 (9.6)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the TS who provided at least 1 primary or secondary PK parameter that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints.

Primary outcome: Mass Balance Recovery of Total [14C]-Radioactivity in Faeces (Fefaeces, 0-t2)

Time frame: PKfaeces samples were collected within 2 hours predose and within 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of dose excreted (%)

Measure	[14C] BI 425809 n = 6
Value	48.3 (14.3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: From study start until end of study, up to 62 days. Serious and other adverse events: From drug administration until end of residual effect period (REP) of 11 days, up to 11 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 425809 XX (C-14)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34936055Burkard U, Desch M, Shatillo Y, Wunderlich G, Mack SR, Schlecker C, Teitelbaum AM, Liu P, Chan TS. The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [14C]-BI 425809 in Healthy Males. Clin Drug Investig. 2022 Jan;42(1):87-99. doi: 10.1007/s40261-021-01111-9. Epub 2021 Dec 22.
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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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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 BI 425809 mixed with [C-14] BI425809 in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.

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 6 inclusion and 22 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: finished, as of the sponsor's last update on 27 Mar 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 Netherlands. 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?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mass Balance Recovery of Total [14C]-Radioactivity in Urine (Feurine, 0-t2) (time frame: PKurine samples were collected within 2 hours predose and within 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 485-509 and 653-677 hours after dosing on Day 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654170, which also lists 1 linked publication.

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 27 Mar 2026.