HealthyPhase 1NCT06139315
A Study to Test How Well Different Doses of BI 765845 Are Tolerated by Healthy People
A Phase 1 study testing BI 765845 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 (PK) of BI 765845 in healthy male subjects and female subjects of non-childbearing potential following intravenous administration of single rising doses. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 765845
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jun 2022to 7 Jun 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female 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
- Age of 18 to 65 years (inclusive)
- BMI of 18.5 to 29.9 kg/m2 (inclusive). Subjects should have a minimum bodyweight of at least 50 kg (inclusive).
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male subject, who meets any of the following criteria for a highly effective contraception from at least screening until at least 90 days after drug administration:
- Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal) by female woman of childbearing potential (WOCBP) partner, plus condom in male subject
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- Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants) by female WOCBP partner, plus condom in male subject
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) by female WOCBP partner, plus condom in male subject
- Male subject is sexually abstinent
- Male subject is vasectomised (vasectomy at least 1 year prior to enrolment) and received medical assessment of the surgical success (documented absence of sperm)
- Female partner is surgically sterilised (including hysterectomy)
- Female partner is postmenopausal, defined as no menses for at least 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory, if available) or
- Female subject of non-childbearing potential, who meets any of the following criteria:
- Female subject is surgically sterilised (including hysterectomy)
- Female subject is postmenopausal, defined as no menses for at least 1 year without an alternative medical cause (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L at screening is confirmatory)
- Male subjects are required to use condoms to prevent unintended exposure of their partner (both, male and female) to the trial drug via seminal fluid and should therefore use a condom at least from time point of administration of trial medication until completion of the trial. Alternatively, true abstinence is 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 above. Male subjects should not donate sperm for the duration of the trial until at least 90 days after drug administration.
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
- 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)
- 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 (including any history of cardiovascular diseases such as atherosclerosis, previous myocardial infarction or angina pectoris)
- Diseases of the central nervous system (including but not limited to any kind of seizures or history of stroke), and other relevant neurological or psychiatric disorders
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- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Randomised, Placebo-controlled, Parallel Group Design Phase I Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Different Doses (Part A) and Different Treatment Regimens (Part B) of BI 765845 Administered to Healthy Male Subjects and Female Subjects of Non-childbearing Potential
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 765845 in healthy male subjects and female subjects of non-childbearing potential following intravenous administration of single rising doses.
- Conditions
- Healthy
- Being tested
- BI 765845, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 765845Drug
BI 765845
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 765845 treatment group (Part A) | Experimental | Part A Receives: Drug: BI 765845 |
| BI 765845 treatment group (Part B) | Experimental | Part B Receives: Drug: BI 765845 |
| Placebo group | Placebo comparator | Part A and B Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with treatment-emergent adverse events
Measured: Up to 73 days
Secondary outcomes (2)
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to Day 71
Maximum measured concentration of the analyte in serum (Cmax)
Measured: Up to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Jun 2022
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
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
- 92 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
- NCT06139315
- Sponsor's protocol ID
- 1478-0001
- Other IDs
- 2021-004733-36
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 28 Nov 2023
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomised, Placebo-controlled, Parallel Group Design Phase I Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Different Doses (Part A) and Different Treatment Regimens (Part B) of BI 765845 Administered to Healthy Male Subjects and Female Subjects of Non-childbearing Potential
- ClinicalTrials.gov ID
- NCT06139315
- Acronym / sponsor ID
- 1478-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 18 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 main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 765845 in healthy male subjects and female subjects of non-childbearing potential following intravenous administration of single rising doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 765845 treatment group (Part A) | Experimental | Drug: BI 765845Part A |
| BI 765845 treatment group (Part B) | Experimental | Drug: BI 765845Part B |
| Placebo group | Placebo comparator | Drug: PlaceboPart A and B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy male or female 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
- Age of 18 to 65 years (inclusive)
- BMI of 18.5 to 29.9 kg/m2 (inclusive). Subjects should have a minimum bodyweight of at least 50 kg (inclusive).
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male subject, who meets any of the following criteria for a highly effective contraception from at least screening until at least 90 days after drug administration:
Key exclusion criteria (9 listed)
- Any finding in the medical examination (including BP, PR 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)
- 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 (including any history of cardiovascular diseases such as atherosclerosis, previous myocardial infarction or angina pectoris)
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 765845BI 765845 | Drug | BI 765845 treatment group (Part A), BI 765845 treatment group (Part B) |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
Percentage of subjects with treatment-emergent adverse events
Time frame: Up to 73 days
2 secondary outcomes
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to Day 71
Maximum measured concentration of the analyte in serum (Cmax)
Time frame: Up to Day 71
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 28 Nov 2023.
- 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 765845 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 16 inclusion and 9 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 28 Nov 2023. 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. 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?
Percentage of subjects with treatment-emergent adverse events (time frame: Up to 73 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 28 Nov 2023.