HealthyPhase 1NCT06232252
A Study to Test How Well Multiple Doses of BI 765423 Are Tolerated by Healthy Men
A Phase 1 study testing BI 765423 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.
Trial summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 765423 in healthy male subjects. 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 765423
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBelgium
- Study dates
- 6 May 2024to 29 Apr 2025
- 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 55 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), respiratory rate (RR), temperature), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male subjects who are willing to not donate sperm for the duration of the trial until completion of EoS visit and meet at least one of the following criteria:
- Not sexually active with a partner of child-bearing potential or sexually abstinent. Women of non-childbearing potential are defined as postmenopausal for at least 1 year or surgically sterilised by hysterectomy, bilateral salpingectomy or bilateral oophorectomy. True abstinence is only acceptable, if it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active, but becomes active with their partner, they must comply with the contraceptive requirements detailed below.
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- Sexually active with a partner of child-bearing potential who is willing to use combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom in male subject from Screening until at least end of study (EoS) visit.
- Sexually active with a partner of child-bearing potential who is willing to use progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom in male subject from Screening until at least EoS visit.
- Sexually active with a partner of child-bearing potential who is willing to use intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), plus condom in male subject from Screening until at least EoS visit.
- Male subject is vasectomised (vasectomy at least 1 year prior to enrolment) and received medical assessment of the surgical success (documented absence of sperm). If sexually active with a partner of child-bearing potential, the subject is willing to use male condom from Screening until at least EoS visit.
Who cannot join
- Any finding in the medical examination (including BP, PR, RR, temperature or 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 beats per minute (bpm) (subjects with heart rate values between 45 and 50 bpm may be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism)
- Any 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
- Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned after screening during the study, e.g. hip replacement
- 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, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 765423 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 765423 in healthy male subjects.
- Conditions
- Healthy
- Being tested
- BI 765423, Placebo matching BI 765423
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 765423Drug
BI 765423
Placebo matching BI 765423Drug
Placebo matching BI 765423
| Study group | Role | What they receive |
|---|---|---|
| Dose group (DG) 1 (very low dose) | Experimental | Not described Receives: Drug: BI 765423; Drug: Placebo matching BI 765423 |
| Dose group (DG) 2 (low dose) | Experimental | Not described Receives: Drug: BI 765423; Drug: Placebo matching BI 765423 |
| Dose group (DG) 3 (medium dose) | Experimental | Not described Receives: Drug: BI 765423; Drug: Placebo matching BI 765423 |
| Dose group (DG) 4 (high dose) | Experimental | Not described Receives: Drug: BI 765423; Drug: Placebo matching BI 765423 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects treated with BI 765423 who experience any treatment-emergent adverse event assessed as drug-related by the investigator
Measured: up to 145 days for DG 1 and 2, up to 159 days for DG 3 and 4
Secondary outcomes (2)
AUCτ (area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ)
Measured: up to 336 hours for DG 1 and 2, up to 673 hours for DG 3 and 4
Cmax (maximum measured concentration of the analyte in serum)
Measured: up to 141 days for DG 1 and 2, up to 155 days for DG 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start6 May 2024
- Primary completion25 Apr 2025
- Study completion29 Apr 2025
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
- Model description
- The groups will be dosed sequentially. Within each dose group, some subjects will receive BI 765423 and some will receive placebo.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 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
- NCT06232252
- Sponsor's protocol ID
- 1493-0008
- Other IDs
- 2023-506722-36-00, U1111-1298-0452, 2023
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2024
- Last updated
- 25 Jun 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. 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 765423 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT06232252
- Acronym / sponsor ID
- 1493-0008
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 30 Jan 2024 (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 of BI 765423 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- The groups will be dosed sequentially. Within each dose group, some subjects will receive BI 765423 and some will receive placebo.
| Arm | Type | Receives |
|---|---|---|
| Dose group (DG) 1 (very low dose) | Experimental | Drug: BI 765423, Drug: Placebo matching BI 765423 |
| Dose group (DG) 2 (low dose) | Experimental | Drug: BI 765423, Drug: Placebo matching BI 765423 |
| Dose group (DG) 3 (medium dose) | Experimental | Drug: BI 765423, Drug: Placebo matching BI 765423 |
| Dose group (DG) 4 (high dose) | Experimental | Drug: BI 765423, Drug: Placebo matching BI 765423 |
Who may qualify
- Ages
- 18 to 55 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), respiratory rate (RR), temperature), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male subjects who are willing to not donate sperm for the duration of the trial until completion of EoS visit and meet at least one of the following criteria:
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including BP, PR, RR, temperature or 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 beats per minute (bpm) (subjects with heart rate values between 45 and 50 bpm may be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism)
- Any 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 |
|---|---|---|
| BI 765423BI 765423 | Drug | Dose group (DG) 1 (very low dose), Dose group (DG) 2 (low dose), Dose group (DG) 3 (medium dose), Dose group (DG) 4 (high dose) |
| Placebo matching BI 765423Placebo matching BI 765423 | Drug | Dose group (DG) 1 (very low dose), Dose group (DG) 2 (low dose), Dose group (DG) 3 (medium dose), Dose group (DG) 4 (high dose) |
Primary outcome
Percentage of subjects treated with BI 765423 who experience any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: up to 145 days for DG 1 and 2, up to 159 days for DG 3 and 4
2 secondary outcomes
AUCτ (area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ)
Time frame: up to 336 hours for DG 1 and 2, up to 673 hours for DG 3 and 4
Cmax (maximum measured concentration of the analyte in serum)
Time frame: up to 141 days for DG 1 and 2, up to 155 days for DG 3 and 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 25 Jun 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. 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 765423 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 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 25 Jun 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 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?
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?
Percentage of subjects treated with BI 765423 who experience any treatment-emergent adverse event assessed as drug-related by the investigator (time frame: up to 145 days for DG 1 and 2, up to 159 days for DG 3 and 4). 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 25 Jun 2025.