HealthyPhase 1NCT05550636

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood

A Phase 1 study testing BI 1015550 and midazolam in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam. 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 1015550 and midazolam
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteGermany
Study dates: 11 Oct 2022to 19 Dec 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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)), 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

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 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
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

Show all 9Show fewer

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.

Germany1 site

CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167

Other trials in Germany

About this study

Official title: The Effect of Multiple Oral Doses of BI 1015550 on Metabolism of Midazolam Administered Orally in Healthy Male Subjects (Open-label, Two-period Fixed Sequence Design Trial)

The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.

Conditions: Healthy
Being tested: BI 1015550, midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 1015550Drug
Also called Nerandomilast, JASCAYD®
BI 1015550
midazolamDrug
midazolam

Study groups in NCT05550636
Study group	Role	What they receive
BI 1015550 + midazolam treatment arm	Experimental	test and reference treatment arm Receives: Drug: BI 1015550; Drug: midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Detailed timeframe:
For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1.
For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.
Measured: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.
Maximum Measured Concentration of Midazolam in Plasma (Cmax)
Maximum measured concentration of midazolam in plasma (Cmax).
Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.
Measured: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.

Secondary outcomes (1)

Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.
Measured: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 202219 Dec 2022

First posted22 Sep 2022
Study start11 Oct 2022
Primary completion19 Dec 2022
Study completion19 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05550636
Sponsor's protocol ID: 1305-0033
Other IDs: 2022-002249-16
Status last verified: Oct 2025
First submitted: 20 Sep 2022
Last updated: 1 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Multiple Oral Doses of BI 1015550 on Metabolism of Midazolam Administered Orally in Healthy Male Subjects (Open-label, Two-period Fixed Sequence Design Trial)
ClinicalTrials.gov ID: NCT05550636
Acronym / sponsor ID: 1305-0033
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 11 Oct 2022 (actual)
Primary completion: 19 Dec 2022 (actual)
Study completion: 19 Dec 2022 (actual)
First posted: 22 Sep 2022 (actual)
Results: Posted 1 Dec 2025

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 induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 1015550 + midazolam treatment arm	Experimental	Drug: BI 1015550, Drug: midazolamtest and reference treatment arm

Who may qualify

Ages: 18 to 55 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
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

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 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

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 1015550Also: Nerandomilast, JASCAYD®BI 1015550	Drug	BI 1015550 + midazolam treatment arm
midazolammidazolam	Drug	BI 1015550 + midazolam treatment arm

Primary outcome

Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.
Maximum Measured Concentration of Midazolam in Plasma (Cmax)
Time frame: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.
Maximum measured concentration of midazolam in plasma (Cmax). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.

1 secondary outcome

Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.

Results and safety

Results posted to the registry on 1 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Midazolam (R) / BI 1015550 + Midazolam (T)	15	15

Primary outcome: Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.. Geometric least squares mean (Standard Error). Unit: Hours * nanomol per liter (h*nmol/L)

Measure	Midazolam (R) n = 15	BI 1015550 + Midazolam (T) n = 15
Value	75.1 (NA)	69.3 (NA)

Midazolam (R) vs BI 1015550 + Midazolam (T): adjusted gMean Ratio (%): 92.3 (90% CI 79.3 to 107.4)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the treated set who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.

Primary outcome: Maximum Measured Concentration of Midazolam in Plasma (Cmax)

Measure	Midazolam (R) n = 15	BI 1015550 + Midazolam (T) n = 15
Value	28.0 (NA)	21.8 (NA)

Midazolam (R) vs BI 1015550 + Midazolam (T): adjusted gmean Ratio (%): 78.0 (90% CI 68.9 to 88.2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Midazolam	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
BI 1015550	0 of 15 (0%)	9 of 15 (60%)	0 of 15
BI 101550 + Midazolam	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 1015550 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 4 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 1 Dec 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?

Yes. Results are posted in the registry (first posted 1 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.). 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?

On the ClinicalTrials.gov record for NCT05550636.

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 1 Dec 2025.