HealthyPhase 1NCT02383888
Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects
A Phase 1 study testing BI 425809 in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.
Trial summary
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product. Read more about this study
- Who is it for?
- Ages 20 to 45 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?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2015to 6 Aug 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- 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 20 to 45 years (incl.)
- BMI 18.5 to 25 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
- Chinese ethnicity, Japanese ethnicity according to the following criteria:
- Chinese: ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
- Japanese: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or PR <50 or >90
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged 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
Show all 25Show fewer
- Diseases of the central nervous system (including by not limited to any kind of seizures or stroke), other neurological disorders or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half- lives of the respective drug prior to administration of trial medication
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 20 g per day)
- 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 one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- At screening, a marked baseline prolongation of QT/QTcF interval (such as repeated demonstration of a QTcF interval greater than 450 ms or any other relevant ECG finding
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
- Evidence or history of macular degeneration or any abnormal finding in color discrimination test, and any other clinically significant ophthalmic disorders based on the investigator's discretion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
1346.4.82001 Boehringer Ingelheim Investigational Site
Busan
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Japanese and Chinese Male Subjects (Randomized, Double-blind, Placebo-controlled Design Within Dose Groups)
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product.
- Conditions
- Healthy
- Being tested
- BI 425809, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 425809Drug
Also called Iclepertin
Single dose administered orally as tablets with 240 mL water after an overnight fast of at least 10 hours
PlaceboDrug
Single dose matching BI 425809 administered as tablets orally with 240 mL of water after an overnight fast of at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment. Receives: Drug: Placebo |
| BI 425809 10 mg Tablet | Experimental | The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet*2) orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 425809 |
| BI 425809 25 mg Tablet | Experimental | The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 425809 |
| BI 425809 50 mg Tablet | Experimental | The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet*2) orally with 240 mL water after an overnight fast of at least 10 hours. Receives: Drug: BI 425809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Drug-Related Adverse Events (AEs)
This outcome measure presents the number of subjects with drug-related adverse events.
Measured: Up to 11 days after drug administration.
Secondary outcomes (5)
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
This outcome measure presents maximum measured concentration of BI 425809 in plasma (Cmax).
Measured: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-∞) Time Curve of BI 425809
This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Measured: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-tz) Time Curve of BI 425809
This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz).
Measured: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Tmax of BI 425809
This outcome measure presents time from dosing to the maximum concentration of BI 425809 in plasma (tmax).
Measured: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
t1/2 of BI 425809
This outcome measure presents terminal half-life of BI 425809 in plasma (t1/2).
Measured: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start11 May 2015
- Primary completion6 Aug 2015
- Study completion6 Aug 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383888
- Sponsor's protocol ID
- 1346.4
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2015
- Last updated
- 30 Mar 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.mystudywindow.com/msw/datatransparency
Publications
Tsuda Y, Ugai H, Wunderlich G, Shin JG. Pharmacokinetics of Single Doses of BI 425809 in Healthy Chinese and Japanese Subjects: A Randomized Study. Clin Ther. 2019 May;41(5):961-971. doi: 10.1016/j.clinthera.2019.03.014. Epub 2019 Apr 17.
PubMed 31005336
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Japanese and Chinese Male Subjects (Randomized, Double-blind, Placebo-controlled Design Within Dose Groups)
- ClinicalTrials.gov ID
- NCT02383888
- Acronym / sponsor ID
- 1346.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 May 2015 (actual)
- Primary completion
- 6 Aug 2015 (actual)
- Study completion
- 6 Aug 2015 (actual)
- First posted
- 10 Mar 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.
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment. |
| BI 425809 10 mg Tablet | Experimental | Drug: BI 425809The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet*2) orally with 240 mL water after an overnight fast of at least 10 hours. |
| BI 425809 25 mg Tablet | Experimental | Drug: BI 425809The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours. |
| BI 425809 50 mg Tablet | Experimental | Drug: BI 425809The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet*2) orally with 240 mL water after an overnight fast of at least 10 hours. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 20 to 45 years (incl.)
- BMI 18.5 to 25 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
- Chinese ethnicity, Japanese ethnicity according to the following criteria:
Key exclusion criteria (25 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or PR <50 or >90
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged 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: IclepertinSingle dose administered orally as tablets with 240 mL water after an overnight fast of at least 10 hours | Drug | BI 425809 10 mg Tablet, BI 425809 25 mg Tablet, BI 425809 50 mg Tablet |
| PlaceboSingle dose matching BI 425809 administered as tablets orally with 240 mL of water after an overnight fast of at least 10 hours. | Drug | Placebo |
Primary outcome
Number of Subjects With Drug-Related Adverse Events (AEs)
Time frame: Up to 11 days after drug administration.
This outcome measure presents the number of subjects with drug-related adverse events.
5 secondary outcomes
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-∞) Time Curve of BI 425809
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-tz) Time Curve of BI 425809
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Tmax of BI 425809
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
t1/2 of BI 425809
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31005336Tsuda Y, Ugai H, Wunderlich G, Shin JG. Pharmacokinetics of Single Doses of BI 425809 in Healthy Chinese and Japanese Subjects: A Randomized Study. Clin Ther. 2019 May;41(5):961-971. doi: 10.1016/j.clinthera.2019.03.014. Epub 2019 Apr 17.
- 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
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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 South Korea.
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 7 inclusion and 25 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 30 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Number of Subjects With Drug-Related Adverse Events (AEs) (time frame: Up to 11 days after drug administration.). 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 NCT02383888, 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 30 Mar 2026.