HealthyPhase 1NCT02362516

Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

A Phase 1 study testing BI 425809 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

Completed

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

Trial summary

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid. 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?: BI 425809
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteBelgium
Study dates: 23 Feb 2015to 19 Jun 2015
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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (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 good clinical practice (GCP) and local legislation

Who cannot join

Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator
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
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Belgium1 site

1346.3.32001 Boehringer Ingelheim Investigational Site
Antwerp

Other trials in Belgium

About this study

Official title: Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers

Conditions: Healthy
Being tested: BI 425809

What participants receive

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

BI 425809Drug
Also called Iclepertin
Tablet

Study groups in NCT02362516
Study group	Role	What they receive
BI 425809 5 mg	Experimental	Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days. Receives: Drug: BI 425809
BI 425809 10 mg	Experimental	Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days. Receives: Drug: BI 425809
BI 425809 25 mg	Experimental	Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days. Receives: Drug: BI 425809
BI 425809 50 mg	Experimental	Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days. Receives: Drug: BI 425809

What is being measured

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

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).
Measured: 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)
Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).
Measured: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
Maximum measured concentration of BI 425809 in plasma is reported.
Time Frame:
0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.
Measured: 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).
Maximum Measured Concentration of BI 425809 in CSF (Cmax)
Maximum measured concentration of BI 425809 in CSF is reported.
Measured: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in Plasma at the Time Point 312h (C312)
Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.
Measured: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in CSF at the Time Point 312h (C312)
Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.
Measured: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.

Secondary outcomes (1)

Percentage of Participants With Drug-related Adverse Events (AEs)
Percentage of participants with drug-related adverse events (AEs).
Measured: From the first drug administration until 11 days after the last drug administration, up to 30days.

Timeline

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

23 Feb 201519 Jun 2015

First posted13 Feb 2015 (estimated)
Study start23 Feb 2015
Primary completion19 Jun 2015
Study completion19 Jun 2015

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.
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: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02362516
Sponsor's protocol ID: 1346.3
Other IDs: 2014-005652-26, 2014
Status last verified: Apr 2026
First submitted: 9 Feb 2015
Last updated: 1 May 2026
Results posted: Yes, on ClinicalTrials.gov
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

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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02362516
Acronym / sponsor ID: 1346.3
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 23 Feb 2015 (actual)
Primary completion: 19 Jun 2015 (actual)
Study completion: 19 Jun 2015 (actual)
First posted: 13 Feb 2015 (estimated)
Results: Posted 30 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
BI 425809 5 mg	Experimental	Drug: BI 425809Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
BI 425809 10 mg	Experimental	Drug: BI 425809Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
BI 425809 25 mg	Experimental	Drug: BI 425809Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
BI 425809 50 mg	Experimental	Drug: BI 425809Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (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 good clinical practice (GCP) and local legislation

Key exclusion criteria (7 listed)

Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator
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
Gastrointestinal, hepatic, renal, respiratory, 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 425809Also: IclepertinTablet	Drug	BI 425809 10 mg, BI 425809 25 mg, BI 425809 5 mg, BI 425809 50 mg

Primary outcome

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)
Time frame: 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).
Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)
Time frame: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
Time frame: 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).
Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.
Maximum Measured Concentration of BI 425809 in CSF (Cmax)
Time frame: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
Maximum measured concentration of BI 425809 in CSF is reported.
Concentration of BI 425809 in Plasma at the Time Point 312h (C312)
Time frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.
Concentration of BI 425809 in CSF at the Time Point 312h (C312)
Time frame: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.

1 secondary outcome

Percentage of Participants With Drug-related Adverse Events (AEs)
Time frame: From the first drug administration until 11 days after the last drug administration, up to 30days.

Results and safety

Results posted to the registry on 30 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 5 mg	6	5
BI 425809 10 mg	6	4
BI 425809 25 mg	8	8
BI 425809 50 mg	5	5

Primary outcome: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)

Time frame: 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.. Geometric mean (Geometric Coefficient of Variation). Unit: nanomole*hours/Liter (nmol∙h/L)

Measure	BI 425809 5 mg n = 6	BI 425809 10 mg n = 6	BI 425809 25 mg n = 7	BI 425809 50 mg n = 5
Value	421.0 (17.6)	829 (18.9)	1840.0 (24.2)	3300.0 (29.3)

BI 425809 5 mg vs BI 425809 10 mg vs BI 425809 25 mg vs BI 425809 50 mg: Slope: 0.8933 (95% CI 0.7863 to 1.0002)

Population analysed: The PK analysis set (PKS) included all subjects from the Treated Set (TS) who provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported.

Primary outcome: Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)

Time frame: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol∙h/L

Measure	BI 425809 5 mg n = 6	BI 425809 10 mg n = 6	BI 425809 25 mg n = 6	BI 425809 50 mg n = 5
Value	29.9 (15.4)	59.8 (19.3)	124.0 (27.2)	260.0 (29.1)

BI 425809 5 mg vs BI 425809 10 mg vs BI 425809 25 mg vs BI 425809 50 mg: Slope: 0.9183 (95% CI 0.8068 to 1.0298)

Population analysed: PKS. Only participants with evaluable results for this PK parameter are reported.

Primary outcome: Maximum Measured Concentration of BI 425809 in Plasma (Cmax)

Time frame: 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).. Geometric mean (Geometric Coefficient of Variation). Unit: nanomole/Liter (nmol/L)

Measure	BI 425809 5 mg n = 6	BI 425809 10 mg n = 6	BI 425809 25 mg n = 7	BI 425809 50 mg n = 5
Value	42.3 (23.2)	85.6 (19.5)	176 (22.6)	328 (37.5)

BI 425809 5 mg vs BI 425809 10 mg vs BI 425809 25 mg vs BI 425809 50 mg: Slope: 0.8757 (95% CI 0.7541 to 0.9973)

Population analysed: PKS. Only participants with evaluable results for this PK parameter are reported.

Primary outcome: Maximum Measured Concentration of BI 425809 in CSF (Cmax)

Time frame: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	BI 425809 5 mg n = 6	BI 425809 10 mg n = 6	BI 425809 25 mg n = 7	BI 425809 50 mg n = 5
Value	2.91 (21.3)	5.59 (17.5)	12.2 (26.4)	25.0 (37.5)

BI 425809 5 mg vs BI 425809 10 mg vs BI 425809 25 mg vs BI 425809 50 mg: Slope: 0.9184 (95% CI 0.7960 to 1.0408)

Population analysed: PKS. Only participants with evaluable results for this PK parameter are reported.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the first drug administration until 11 days after the last drug administration, up to 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 425809 5 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
BI 425809 10 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
BI 425809 25 mg	0 of 8 (0%)	8 of 8 (100%)	Not reported
BI 425809 50 mg	0 of 5 (0%)	4 of 5 (80%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

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 4 inclusion and 7 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 1 May 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 Belgium. 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 30 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?

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) (time frame: 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.). The study lists 6 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 NCT02362516.

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 1 May 2026.