HealthyPhase 1NCT05183347
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated
A Phase 1 study testing BI 1291583 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 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1291583
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 4 Feb 2022to 27 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- 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 at screening visit
- 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 visit
- BMI of 18.5 to 25.0 kilograms divided by height in meters squared (kg/m2) (inclusive) at screening visit
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
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- Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
- Vasectomized (vasectomy at least 1 year prior to enrolment)
- Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner
Who cannot join
- Any finding in the medical examination (including BP, PR, or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening visit
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
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- Chronic or relevant acute infections including viral hepatitis human immunodeficiency virus (HIV) and/or syphilis
- History of cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- 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 [QT: Time between start of the Q-wave and the end of the T-wave in an electrocardiogram, QTc: QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB)]
- Futher exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1291583 in Healthy Male Japanese Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
- Conditions
- Healthy
- Being tested
- BI 1291583, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1291583Drug
Also called Verducatib
BI 1291583
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SRD: Dose Group 1 | Experimental | SRD: single-rising dose Receives: Drug: BI 1291583 |
| SRD: Dose Group 2 | Experimental | SRD: single-rising dose Receives: Drug: BI 1291583 |
| SRD: Dose Group 3 | Experimental | SRD: single-rising dose Receives: Drug: BI 1291583 |
| MD: Dose Group 4 | Experimental | MD: multiple doses Receives: Drug: BI 1291583 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Measured: up to 65 days
Secondary outcomes (6)
SRD: Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
SRD: single-rising dose
Measured: up to 29 days
SRD: Maximum measured concentration of BI 1291583 in plasma (Cmax)
SRD: single-rising dose
Measured: up to 29 days
MD: After the first dose: Area under the concentration-time curve of BI 1291583 in plasma over a uniform dosing interval τ (AUCτ,1)
MD: multiple doses
Measured: up to 24 hours
MD: After the first dose: Maximum measured concentration of BI 1291583 in plasma (Cmax,1)
MD: multiple doses
Measured: up to 24 hours
MD: After the last dose: Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
MD: multiple doses
Measured: at day 28
MD: After the last dose: Maximum measured concentration of BI 1291583 in plasma at steady state (Cmax,ss)
MD: multiple doses
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start4 Feb 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT05183347
- Sponsor's protocol ID
- 1397-0003
- Status last verified
- Aug 2025
- First submitted
- 22 Dec 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 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 and Multiple Oral Doses of BI 1291583 in Healthy Male Japanese Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT05183347
- Acronym / sponsor ID
- 1397-0003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SRD: Dose Group 1 | Experimental | Drug: BI 1291583SRD: single-rising dose |
| SRD: Dose Group 2 | Experimental | Drug: BI 1291583SRD: single-rising dose |
| SRD: Dose Group 3 | Experimental | Drug: BI 1291583SRD: single-rising dose |
| MD: Dose Group 4 | Experimental | Drug: BI 1291583MD: multiple doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 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 at screening visit
- 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 visit
- BMI of 18.5 to 25.0 kilograms divided by height in meters squared (kg/m2) (inclusive) at screening visit
- 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 (12 listed)
- Any finding in the medical examination (including BP, PR, or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening visit
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- History of cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
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 1291583Also: VerducatibBI 1291583 | Drug | MD: Dose Group 4, SRD: Dose Group 1, SRD: Dose Group 2, SRD: Dose Group 3 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: up to 65 days
6 secondary outcomes
SRD: Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 29 days
SRD: Maximum measured concentration of BI 1291583 in plasma (Cmax)
Time frame: up to 29 days
MD: After the first dose: Area under the concentration-time curve of BI 1291583 in plasma over a uniform dosing interval τ (AUCτ,1)
Time frame: up to 24 hours
MD: After the first dose: Maximum measured concentration of BI 1291583 in plasma (Cmax,1)
Time frame: up to 24 hours
MD: After the last dose: Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: at day 28
MD: After the last dose: Maximum measured concentration of BI 1291583 in plasma at steady state (Cmax,ss)
Time frame: at day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- 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 BI 1291583 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 9 inclusion and 12 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 13 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator (time frame: up to 65 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.