HealthyPhase 1NCT05965583

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood

A Phase 1 study testing BI 1815368 and Itraconazole 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 effect on the exposure of BI 1815368 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R). 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 1815368 and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteGermany
Study dates: 2 Aug 2023to 24 Oct 2023
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, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) (inclusive)
Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Who cannot join

Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

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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
Relevant chronic or acute infections
Further exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1815368 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)

Conditions: Healthy
Being tested: BI 1815368, Itraconazole

What participants receive

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

BI 1815368Drug
BI 1815368
ItraconazoleDrug
Also called Sempera®
Itraconazole

Study groups in NCT05965583
Study group	Role	What they receive
BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)	Experimental	Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R. On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days. Receives: Drug: BI 1815368; Drug: Itraconazole

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 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale.
The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Measured: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.
Maximum Measured Concentration of BI 1815368 in Plasma (Cmax)
Maximum measured concentration (Cmax) of BI 1815368 in plasma is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.
Measured: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 1815368 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.
Measured: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.

Timeline

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

2 Aug 202324 Oct 2023

First posted28 Jul 2023
Study start2 Aug 2023
Primary completion24 Oct 2023
Study completion24 Oct 2023

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: Crossover
Model description: Participants cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05965583
Sponsor's protocol ID: 1485-0003
Other IDs: 2023-503783-16-00, 2023
Status last verified: Apr 2026
First submitted: 19 Jul 2023
Last updated: 12 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1815368 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)
ClinicalTrials.gov ID: NCT05965583
Acronym / sponsor ID: 1485-0003
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 2 Aug 2023 (actual)
Primary completion: 24 Oct 2023 (actual)
Study completion: 24 Oct 2023 (actual)
First posted: 28 Jul 2023 (actual)
Results: Posted 12 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1
Model description: Participants cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).

Arm	Type	Receives
BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)	Experimental	Drug: BI 1815368, Drug: ItraconazoleSubjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R. On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days.

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, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) (inclusive)
Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Key exclusion criteria (10 listed)

Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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

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 1815368BI 1815368	Drug	BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)
ItraconazoleAlso: Sempera®Itraconazole	Drug	BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T)

Primary outcome

Area Under the Concentration-time Curve of BI 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Maximum Measured Concentration of BI 1815368 in Plasma (Cmax)
Time frame: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.
Maximum measured concentration (Cmax) of BI 1815368 in plasma is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint.

1 secondary outcome

Area Under the Concentration-time Curve of BI 1815368 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.

Results and safety

Results posted to the registry on 12 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 1815368 (R), Then Itraconazole and BI 1815368 (T)	14	14

Primary outcome: Area Under the Concentration-time Curve of BI 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Time frame: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.. Geometric least squares mean (Standard Error). Unit: nanomoles*hour/Liter (nmol*h/L)

Measure	BI 1815368 (R) Alone n = 14	Itraconazole and BI 1815368 (T) n = 13
Value	3876.73 (NA)	8178.83 (NA)

BI 1815368 (R) Alone vs Itraconazole and BI 1815368 (T): Ratio of adjusted geometric means (T/R): 210.97 (90% CI 195.44 to 227.74)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of a PK endpoint 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. Only subjects with available PK data were included in this analysis.

Primary outcome: Maximum Measured Concentration of BI 1815368 in Plasma (Cmax)

Measure	BI 1815368 (R) Alone n = 14	Itraconazole and BI 1815368 (T) n = 13
Value	704.47 (NA)	847.84 (NA)

BI 1815368 (R) Alone vs Itraconazole and BI 1815368 (T): Ratio of adjusted geometric means (T/R): 120.35 (90% CI 107.39 to 134.88)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1815368 (R) Alone	0 of 14 (0%)	4 of 14 (28.6%)	0 of 14
Itraconazole Alone	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Itraconazole and BI 1815368 (T)	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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 1815368 and Itraconazole 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 10 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 12 May 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?

Yes. Results are posted in the registry (first posted 12 May 2026). 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 BI 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (time frame: Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration.). 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 NCT05965583.

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 12 May 2026.