HealthyPhase 1NCT03875001
A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men
A Phase 1 study testing Dose group 1 - 50 mg BI 1358894, Dose group 2 - 100 mg BI 1358894 and Dose group 3 - 200 mg BI 1358894 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses. 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?
- Dose group 1 - 50 mg BI 1358894, Dose group 2 - 100 mg BI 1358894 and Dose group 3 - 200 mg BI 1358894
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 25 Mar 2019to 20 Jul 2019
- 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 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
- Japanese ethnicity, according to the following criteria:
- -- born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
- Age of 20 to 45 years (inclusive) at screening
- Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive) at screening
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
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- Willingness to comply with contraception requirements. Subjects who are sexually active must use with their female partner, adequate contraception throughout the study and until three months after the last administration of trial medication. Adequate methods are:
- A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or
- Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner or
- The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g., implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g., diaphragm with spermicide) Unprotected sexual intercourse with a pregnant female partner is not allowed throughout the study and until three months after the last administration of trial medication.
Who cannot join
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- C-Reactive Protein (CRP) > upper limit of normal (ULN), erythrocyte sedimentation rate (ESR) ≥ 15 millimeters/hour, liver and kidney parameter above ULN, other 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
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
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- 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 including viral hepatitis, human immunodeficiency virus (HIV) and/or syphilis. (Subject with positive Hepatitis B core antibody will not be allowed to participate in this trial)
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
- Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
- 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 30 g per day for males)
- Drug abuse or positive drug screening
- Blood donation of more than 400 mL within 12 weeks or 200 mL within 30 days or plasma donation within 2 weeks prior to administration or intended blood donation during the trial
- Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
- Inability to comply with the dietary regimen of the 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 Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
- Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought, active suicidal thought with method, active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1358894 in Healthy Japanese Male Subjects (Double-blind, Randomised, Placebo-controlled Parallel Dose Group Design)
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses.
- Conditions
- Healthy
- Being tested
- Placebo, Dose group 1 - 50 mg BI 1358894, Dose group 2 - 100 mg BI 1358894, Dose group 3 - 200 mg BI 1358894
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
Dose group 1 - 50 mg BI 1358894Drug
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
Dose group 2 - 100 mg BI 1358894Drug
1 film-coated tablet of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
Dose group 3 - 200 mg BI 1358894Drug
2 film-coated tablets of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). Receives: Drug: Placebo |
| Dose group 1 - 50 mg BI 1358894 | Experimental | 2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). Receives: Drug: Dose group 1 - 50 mg BI 1358894 |
| Dose group 2 - 100 mg BI 1358894 | Experimental | 1 film-coated tablet of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). Receives: Drug: Dose group 2 - 100 mg BI 1358894 |
| Dose group 3 - 200 mg BI 1358894 | Experimental | 2 film-coated tablets of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). Receives: Drug: Dose group 3 - 200 mg BI 1358894 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Drug Related Adverse Events (AEs).
Percentage of subjects with drug related adverse events (AEs).
Measured: Up to 14 days for 50 mg BI 1358894, 100 mg BI 1358894 and placebo. Up to 33 days for 200 mg BI 1358894.
Secondary outcomes (3)
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz).
AUC0-tz (area under the concentration-time curve of BI 1358894 in plasma over the time interval from the time of administration to the last quantifiable data time point tz).
Measured: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity.
Measured: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
Maximum measured concentration of BI 1358894 in plasma.
Measured: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start25 Mar 2019
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
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
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT03875001
- Sponsor's protocol ID
- 1402-0008
- Status last verified
- Feb 2025
- First submitted
- 8 Mar 2019
- Last updated
- 26 Feb 2025
- 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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Publications
Yoon J, Sharma V, Harada A. Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy Japanese Male Volunteers. Clin Drug Investig. 2024 May;44(5):319-328. doi: 10.1007/s40261-024-01357-z. Epub 2024 Apr 24.
PubMed 38656736
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. 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 1358894 in Healthy Japanese Male Subjects (Double-blind, Randomised, Placebo-controlled Parallel Dose Group Design)
- ClinicalTrials.gov ID
- NCT03875001
- Acronym / sponsor ID
- 1402-0008
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboFor each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). |
| Dose group 1 - 50 mg BI 1358894 | Experimental | Drug: Dose group 1 - 50 mg BI 13588942 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). |
| Dose group 2 - 100 mg BI 1358894 | Experimental | Drug: Dose group 2 - 100 mg BI 13588941 film-coated tablet of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). |
| Dose group 3 - 200 mg BI 1358894 | Experimental | Drug: Dose group 3 - 200 mg BI 13588942 film-coated tablets of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 Electrocardiogram (ECG), and clinical laboratory tests
- Japanese ethnicity, according to the following criteria:
- -- born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
- Age of 20 to 45 years (inclusive) at screening
- Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive) at screening
Key exclusion criteria (24 listed)
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- C-Reactive Protein (CRP) > upper limit of normal (ULN), erythrocyte sedimentation rate (ESR) ≥ 15 millimeters/hour, liver and kidney parameter above ULN, other 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
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 |
|---|---|---|
| PlaceboFor each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). | Drug | Placebo |
| Dose group 1 - 50 mg BI 13588942 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). | Drug | Dose group 1 - 50 mg BI 1358894 |
| Dose group 2 - 100 mg BI 13588941 film-coated tablet of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). | Drug | Dose group 2 - 100 mg BI 1358894 |
| Dose group 3 - 200 mg BI 13588942 film-coated tablets of 100 milligram BI 1358894 taken orally with ~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours). | Drug | Dose group 3 - 200 mg BI 1358894 |
Primary outcome
Percentage of Subjects With Drug Related Adverse Events (AEs).
Time frame: Up to 14 days for 50 mg BI 1358894, 100 mg BI 1358894 and placebo. Up to 33 days for 200 mg BI 1358894.
Percentage of subjects with drug related adverse events (AEs).
3 secondary outcomes
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz).
Time frame: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
Time frame: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38656736Yoon J, Sharma V, Harada A. Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy Japanese Male Volunteers. Clin Drug Investig. 2024 May;44(5):319-328. doi: 10.1007/s40261-024-01357-z. Epub 2024 Apr 24.
- 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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.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 Dose group 1 - 50 mg BI 1358894, Dose group 2 - 100 mg BI 1358894 and Dose group 3 - 200 mg BI 1358894 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
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 10 inclusion and 24 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 26 Feb 2025. 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 Japan. 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 26 Feb 2025). 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?
Percentage of Subjects With Drug Related Adverse Events (AEs). (time frame: Up to 14 days for 50 mg BI 1358894, 100 mg BI 1358894 and placebo. Up to 33 days for 200 mg BI 1358894.). 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 NCT03875001, 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 26 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.