HealthyPhase 1NCT06148948
A Study in Healthy Men to Test How Well Different Doses of BI 1584862 Are Tolerated
A Phase 1 study testing BI 1584862 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
The goal of this trial is to investigate safety, tolerability and pharmacokinetics of BI 1584862 in healthy male subjects of Japanese ethnicity following oral administration of single rising doses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1584862
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 25 Dec 2023to 21 May 2024
- 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 18 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) and 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 18 to 45 years (inclusive) at screening visit.
- Body mass index (BMI) of 18.5 to 24.9 kg/m^2 (inclusive) at screening visit.
- Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of trial medication until 90 days after the last medication:
Show all 10Show fewer
- 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
- Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause
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 40 to 99 mmHg, or pulse rate outside the range of 40 to 99 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
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- 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 Further 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 of BI 1584862 in Japanese Healthy Male Subjects (Single- Masked, Randomised, Placebo-controlled, Parallel Group Design)
The goal of this trial is to investigate safety, tolerability and pharmacokinetics of BI 1584862 in healthy male subjects of Japanese ethnicity following oral administration of single rising doses.
- Conditions
- Healthy
- Being tested
- BI 1584862, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1584862Drug
BI 1584862
PlaceboDrug
Placebo matching BI 1584862
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo matching BI 1584862 Receives: Drug: Placebo |
| BI 1584862 dose group 1 | Experimental | Group receiving dose 1 of BI 1584862 Receives: Drug: BI 1584862 |
| BI 1584862 dose group 2 | Experimental | Group receiving dose 2 of BI 1584862 Receives: Drug: BI 1584862 |
| BI 1584862 dose group 3 | Experimental | Group receiving dose 3 of BI 1584862 Receives: Drug: BI 1584862 |
| BI 1584862 dose group 4 | Experimental | Group receiving dose 4 of BI 1584862 Receives: Drug: BI 1584862 |
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 day 10
Secondary outcomes (2)
Area under the concentration-time curve of plasma BI 1584862 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: Up to day 4
Maximum measured concentration of BI 1584862 in plasma (Cmax)
Measured: Up to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start25 Dec 2023
- Primary completion21 May 2024
- Study completion21 May 2024
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 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
- NCT06148948
- Sponsor's protocol ID
- 1484-0004
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2023
- Last updated
- 13 Nov 2024
- 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. 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. 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 1584862 in Japanese Healthy Male Subjects (Single- Masked, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT06148948
- Acronym / sponsor ID
- 1484-0004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 28 Nov 2023 (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 goal of this trial is to investigate safety, tolerability and pharmacokinetics of BI 1584862 in healthy male subjects of Japanese ethnicity following oral administration of single rising doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching BI 1584862 |
| BI 1584862 dose group 1 | Experimental | Drug: BI 1584862Group receiving dose 1 of BI 1584862 |
| BI 1584862 dose group 2 | Experimental | Drug: BI 1584862Group receiving dose 2 of BI 1584862 |
| BI 1584862 dose group 3 | Experimental | Drug: BI 1584862Group receiving dose 3 of BI 1584862 |
| BI 1584862 dose group 4 | Experimental | Drug: BI 1584862Group receiving dose 4 of BI 1584862 |
Who may qualify
- Ages
- 18 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) and 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 18 to 45 years (inclusive) at screening visit.
- Body mass index (BMI) of 18.5 to 24.9 kg/m^2 (inclusive) at screening visit.
- Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Key exclusion criteria (8 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 40 to 99 mmHg, or pulse rate outside the range of 40 to 99 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
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 1584862BI 1584862 | Drug | BI 1584862 dose group 1, BI 1584862 dose group 2, BI 1584862 dose group 3, BI 1584862 dose group 4 |
| PlaceboPlacebo matching BI 1584862 | Drug | Placebo |
Primary outcome
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: Up to day 10
2 secondary outcomes
Area under the concentration-time curve of plasma BI 1584862 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: Up to day 4
Maximum measured concentration of BI 1584862 in plasma (Cmax)
Time frame: Up to day 4
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 Nov 2024.
- 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.
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 1584862 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 8 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 Nov 2024. 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 day 10). 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 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.