HealthyPhase 1NCT06916702
A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women
A Phase 1 study testing BI 3031185 and Midazolam in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 3031185 and Midazolam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 7 Apr 2025to 15 Nov 2026
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A: 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 Part B: Healthy male and female (women of non-childbearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Part A: Age of 18 to 50 years (inclusive) Part B: Age of 18 to 55 years (inclusive)
- Part A: Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Part B: For female trial participants: Female trial participants who meet any of the following criteria (women of non-childbearing potential):
- Permanently sterilised (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- 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
- Further inclusion criteria apply
Who cannot join
- Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 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
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male and Female Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.
Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3031185Drug
BI 3031185
MidazolamDrug
Midazolam
PlaceboDrug
Placebo matching BI 3031185
| Study group | Role | What they receive |
|---|---|---|
| Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Not described Receives: Drug: BI 3031185; Drug: Midazolam; Drug: Placebo |
| Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Not described Receives: Drug: BI 3031185; Drug: Midazolam; Drug: Placebo |
| Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Not described Receives: Drug: BI 3031185; Drug: Midazolam; Drug: Placebo |
| Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Not described Receives: Drug: BI 3031185; Drug: Midazolam; Drug: Placebo |
| Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Not described Receives: Drug: BI 3031185; Drug: Midazolam; Drug: Placebo |
| Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Not described Receives: Drug: BI 3031185; Drug: Midazolam; Drug: Placebo |
| Part B (receiving BI 3031185 or placebo) | Experimental | Not described Receives: Drug: BI 3031185; 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 Day 54
Secondary outcomes (2)
Area under the concentration-time curve of BI 3031185 in plasma at steady state over a uniform dosing interval τ ((AUC) τ,ss )
Measured: Up to Day 42
Maximum measured concentration of BI 3031185 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: Up to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start7 Apr 2025
- Primary completion23 Sep 2026
- Study completion15 Nov 2026 (estimated)
Why it stopped: Sponsor decision - hold following the evaluation of a safety event. No current sites in the US.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916702
- Sponsor's protocol ID
- 1516-0002
- Other IDs
- 2024-516921-29-00, U1111-1311-3555
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2025
- Last updated
- 27 Oct 2026
- 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male and Female Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT06916702
- Acronym / sponsor ID
- 1516-0002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor decision - hold following the evaluation of a safety event. No current sites in the US.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.
Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Drug: BI 3031185, Drug: Midazolam, Drug: Placebo |
| Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Drug: BI 3031185, Drug: Midazolam, Drug: Placebo |
| Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Drug: BI 3031185, Drug: Midazolam, Drug: Placebo |
| Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Drug: BI 3031185, Drug: Midazolam, Drug: Placebo |
| Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Drug: BI 3031185, Drug: Midazolam, Drug: Placebo |
| Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam) | Experimental | Drug: BI 3031185, Drug: Midazolam, Drug: Placebo |
| Part B (receiving BI 3031185 or placebo) | Experimental | Drug: BI 3031185, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Part A: 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 Part B: Healthy male and female (women of non-childbearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Part A: Age of 18 to 50 years (inclusive) Part B: Age of 18 to 55 years (inclusive)
- Part A: Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Part B: For female trial participants: Female trial participants who meet any of the following criteria (women of non-childbearing potential):
Key exclusion criteria (5 listed)
- Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 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
- Further exclusion criteria apply
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 3031185BI 3031185 | Drug | Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam), Part B (receiving BI 3031185 or placebo) |
| MidazolamMidazolam | Drug | Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam) |
| PlaceboPlacebo matching BI 3031185 | Drug | Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam), Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam), Part B (receiving BI 3031185 or placebo) |
Primary outcome
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: Up to Day 54
2 secondary outcomes
Area under the concentration-time curve of BI 3031185 in plasma at steady state over a uniform dosing interval τ ((AUC) τ,ss )
Time frame: Up to Day 42
Maximum measured concentration of BI 3031185 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: Up to Day 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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 3031185 and Midazolam in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 8 inclusion and 5 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: paused, as of the sponsor's last update on 27 Oct 2026. 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 Germany. 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?
Results are not available in the source record.
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 54). 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 27 Oct 2026.