HealthyPhase 1NCT06255340
A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood
A Phase 1 study testing BI 3031185 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development. 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 3031185
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2024to 28 Aug 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), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
- Age of 18 to 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- 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
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 139 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 89 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
- 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: A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3031185 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3031185 as Tablet With and Without Food in Healthy Male Subjects
This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development.
The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.
- Conditions
- Healthy
- Being tested
- BI 3031185, Placebo matching 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
Placebo matching BI 3031185Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SRD Part: BI 3031185 dose group 1 | Experimental | Single rising dose (SRD) Receives: Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 2 | Experimental | Not described Receives: Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 3 | Experimental | Not described Receives: Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 4 | Experimental | Not described Receives: Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 5 | Experimental | Not described Receives: Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 6 | Experimental | Not described Receives: Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 7 | Experimental | Not described Receives: Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 8 | Experimental | Not described Receives: Drug: BI 3031185 |
| SRD Part: Placebo matching BI 3031185 | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3031185 |
| FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions | Experimental | Food effect (FE) Receives: Drug: BI 3031185 |
| FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions | Experimental | Not described Receives: Drug: BI 3031185 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Measured: Up to 22 days
FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)
Measured: Up to 24 hours
FE part: Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 8 days
Secondary outcomes (3)
SRD part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)
Measured: Up to 24 hours
SRD part: Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 13 days
FE part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start11 Mar 2024
- Primary completion28 Aug 2024
- Study completion28 Aug 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
- Crossover
- Model description
- The food effect (FE) part of the trial is designed as a randomised, two-sequence, open-label, two period, two-way cross-over trial. The single rising dose (SRD) part is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups.
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT06255340
- Sponsor's protocol ID
- 1516-0001
- Status last verified
- Nov 2024
- First submitted
- 5 Feb 2024
- 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
- A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3031185 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3031185 as Tablet With and Without Food in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06255340
- Acronym / sponsor ID
- 1516-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 13 Feb 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.
This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development.
The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 11
- Model description
- The food effect (FE) part of the trial is designed as a randomised, two-sequence, open-label, two period, two-way cross-over trial. The single rising dose (SRD) part is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups.
| Arm | Type | Receives |
|---|---|---|
| SRD Part: BI 3031185 dose group 1 | Experimental | Drug: BI 3031185Single rising dose (SRD) |
| SRD Part: BI 3031185 dose group 2 | Experimental | Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 3 | Experimental | Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 4 | Experimental | Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 5 | Experimental | Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 6 | Experimental | Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 7 | Experimental | Drug: BI 3031185 |
| SRD Part: BI 3031185 dose group 8 | Experimental | Drug: BI 3031185 |
| SRD Part: Placebo matching BI 3031185 | Placebo comparator | Drug: Placebo matching BI 3031185 |
| FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions | Experimental | Drug: BI 3031185Food effect (FE) |
| FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions | Experimental | Drug: BI 3031185 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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 without any clinically significant abnormalities
- Age of 18 to 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- 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
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
- Repeated measurement of systolic blood pressure outside the range of 90 to 139 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 89 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
- 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 3031185BI 3031185 | Drug | FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions, FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions, SRD Part: BI 3031185 dose group 1, SRD Part: BI 3031185 dose group 2, SRD Part: BI 3031185 dose group 3, SRD Part: BI 3031185 dose group 4, SRD Part: BI 3031185 dose group 5, SRD Part: BI 3031185 dose group 6, SRD Part: BI 3031185 dose group 7, SRD Part: BI 3031185 dose group 8 |
| Placebo matching BI 3031185Placebo | Drug | SRD Part: Placebo matching BI 3031185 |
Primary outcome
SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Time frame: Up to 22 days
FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)
Time frame: Up to 24 hours
FE part: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 8 days
3 secondary outcomes
SRD part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)
Time frame: Up to 24 hours
SRD part: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 13 days
FE part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 8 days
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 3031185 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 4 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 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. 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?
SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator (time frame: Up to 22 days). The study lists 3 primary outcomes in all. 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.