HealthyPhase 1NCT06917872
A Study in Healthy People to Test Whether Erythromycin Influences the Amount of BI 1291583 in the Blood
A Phase 1 study testing BI 1291583 and erythromycin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The main objective of this trial is to investigate the effect of erythromycin, a moderate CYP3A4 inhibitor on the pharmacokinetics of BI 1291583 at steady state. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1291583 and erythromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 29 Apr 2025to 9 Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and 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 50 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 Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Male subject, willing to use male contraception (condom or sexual abstinence) and to refrain from sperm donation from time point of administration of trial medication until 90 days after last administration of trial medication, if their sexual partner is a woman of child-bearing potential (WOCBP) or
- Female subject who meets any of the following criteria for a highly effective contraception from at least 30 days prior to first administration of trial medication until 5 months after last administration of trial medication:
Show all 13Show fewer
- Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom in male partner
- Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom in male partner
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), plus condom in male partner
- Sexually abstinent
- Male sexual partner of the trial participant is vasectomized and received medical assessment of the surgical success of the vasectomy (documented absence of sperm)
- Surgically sterilized (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion)
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
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 BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (including but not limited to electrolyte disturbances, particularly hypokalemia and hypomagnesemia)
- Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
- Any known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hormonal or immunological disorders (including any known relevant immunodeficiency)
- 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: An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Erythromycin, a Moderate CYP3A4 Inhibitor, on the Pharmacokinetics of BI 1291583 at Steady State in Healthy Male and Female Subjects
The main objective of this trial is to investigate the effect of erythromycin, a moderate CYP3A4 inhibitor on the pharmacokinetics of BI 1291583 at steady state.
- Conditions
- Healthy
- Being tested
- BI 1291583, erythromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1291583Drug
Also called Verducatib
BI 1291583
erythromycinDrug
erythromycin
| Study group | Role | What they receive |
|---|---|---|
| BI 1291583 alone followed by BI 1291583 + erythromycin | Experimental | Period 1 + period 2 Receives: Drug: BI 1291583; Drug: erythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Measured: Up to 72 days
Maximum measured concentration of BI 1291583 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: Up to 72 days
Secondary outcomes (2)
Time from last dosing to maximum concentration of BI 1291583 in plasma at steady state (tmax,ss)
Measured: Up to 72 days
Minimum concentration of BI 1291583 in plasma at steady state within a uniform dosing interval τ (Cmin,ss)
Measured: Up to 72 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start29 Apr 2025
- Primary completion9 Sep 2025
- Study completion9 Sep 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06917872
- Sponsor's protocol ID
- 1397-0029
- Other IDs
- 2024-515795-12-00, U1111-1310-2268
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2025
- Last updated
- 16 Sep 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Erythromycin, a Moderate CYP3A4 Inhibitor, on the Pharmacokinetics of BI 1291583 at Steady State in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT06917872
- Acronym / sponsor ID
- 1397-0029
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 9 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.
The main objective of this trial is to investigate the effect of erythromycin, a moderate CYP3A4 inhibitor on the pharmacokinetics of BI 1291583 at steady state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 1291583 alone followed by BI 1291583 + erythromycin | Experimental | Drug: BI 1291583, Drug: erythromycinPeriod 1 + period 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male and 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 50 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 Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Male subject, willing to use male contraception (condom or sexual abstinence) and to refrain from sperm donation from time point of administration of trial medication until 90 days after last administration of trial medication, if their sexual partner is a woman of child-bearing potential (WOCBP) or
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 BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (including but not limited to electrolyte disturbances, particularly hypokalemia and hypomagnesemia)
- Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
- Any known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hormonal or immunological disorders (including any known relevant immunodeficiency)
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 1291583Also: VerducatibBI 1291583 | Drug | BI 1291583 alone followed by BI 1291583 + erythromycin |
| erythromycinerythromycin | Drug | BI 1291583 alone followed by BI 1291583 + erythromycin |
Primary outcome
Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: Up to 72 days
Maximum measured concentration of BI 1291583 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: Up to 72 days
2 secondary outcomes
Time from last dosing to maximum concentration of BI 1291583 in plasma at steady state (tmax,ss)
Time frame: Up to 72 days
Minimum concentration of BI 1291583 in plasma at steady state within a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 72 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 16 Sep 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 1291583 and erythromycin 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 13 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 16 Sep 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 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?
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?
Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) (time frame: Up to 72 days). The study lists 2 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 16 Sep 2025.