HealthyPhase 1NCT03403439

This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood

A Phase 1 study testing BI 1015550 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

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 itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: 3 May 2018to 20 Jul 2018
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, based on a complete medical history including a physical examination, vital signs (BP (Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
Age of 18 to 55 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Who cannot join

Any finding in the medical examination (including BP (Blood Pressure), PR (Pulse Rate) or ECG (Electrocardiogram)) is deviating from normal and judged 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 45 to 90 bpm (beats per minute)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 13Show 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, including but not limited to mood disorders and any history of suicidality.
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients or other Azoles )
Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
Further exclusion criteria 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: Relative Bioavailability of a Single Oral Dose of BI 1015550 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects

The primary objective of this trial is to investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the 4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral administration in healthy male subjects.

Conditions: Healthy
Being tested: BI 1015550, itraconazole

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®
single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours
itraconazoleDrug
200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h

Study groups in NCT03403439
Study group	Role	What they receive
BI 1015550 alone (R) / itraconazole + BI 1015550 (T)	Experimental	Participants were administered single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours on Day 1 of Visit 2. Again participants were administered itraconazole plus BI 1015550; participants received 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 days. Receives: Drug: BI 1015550; 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 1015550 in Plasma Over the Time Interval From 0 to 119 Hours
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to 119 hours (h) (AUC0-119). Standard error is actually geometric standard error. Geometric mean (gMean) is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 hours:minutes (h:m) prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Measured: Up to 215 hours (Please check measure description for detailed timeframe)
Maximum Measured Concentration of the BI 1015550 in Plasma
Maximum measured concentration of the BI 1015550 in plasma (Cmax). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Measured: Up to 215 hours (Please check measure description for detailed timeframe)

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Measured: Up to 215 hours (Please check measure description for detailed timeframe)

Timeline

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

3 May 201820 Jul 2018

First posted18 Jan 2018
Study start3 May 2018
Primary completion20 Jul 2018
Study completion20 Jul 2018

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: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03403439
Sponsor's protocol ID: 1305-0015
Other IDs: 2017-003452-23, 2017
Status last verified: Oct 2025
First submitted: 12 Jan 2018
Last updated: 28 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a Single Oral Dose of BI 1015550 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03403439
Acronym / sponsor ID: 1305-0015
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 3 May 2018 (actual)
Primary completion: 20 Jul 2018 (actual)
Study completion: 20 Jul 2018 (actual)
First posted: 18 Jan 2018 (actual)
Results: Posted 28 Nov 2025

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: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 1015550 alone (R) / itraconazole + BI 1015550 (T)	Experimental	Drug: BI 1015550, Drug: itraconazoleParticipants were administered single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours on Day 1 of Visit 2. Again participants were administered itraconazole plus BI 1015550; participants received 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 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, based on a complete medical history including a physical examination, vital signs (BP (Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
Age of 18 to 55 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Key exclusion criteria (13 listed)

Any finding in the medical examination (including BP (Blood Pressure), PR (Pulse Rate) or ECG (Electrocardiogram)) is deviating from normal and judged 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 45 to 90 bpm (beats per minute)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged 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®single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours	Drug	BI 1015550 alone (R) / itraconazole + BI 1015550 (T)
itraconazole200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h	Drug	BI 1015550 alone (R) / itraconazole + BI 1015550 (T)

Primary outcome

Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to 119 Hours
Time frame: Up to 215 hours (Please check measure description for detailed timeframe)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to 119 hours (h) (AUC0-119). Standard error is actually geometric standard error. Geometric mean (gMean) is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 hours:minutes (h:m) prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Maximum Measured Concentration of the BI 1015550 in Plasma
Time frame: Up to 215 hours (Please check measure description for detailed timeframe)
Maximum measured concentration of the BI 1015550 in plasma (Cmax). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.

1 secondary outcome

Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Up to 215 hours (Please check measure description for detailed timeframe)

Results and safety

Results posted to the registry on 28 Nov 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
BI 1015550 alone (R) / itraconazole + BI 1015550 (T)	16	16

Primary outcome: Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to 119 Hours

Time frame: Up to 215 hours (Please check measure description for detailed timeframe). Geometric mean (Standard Error). Unit: nanomole (nmol)*h/Litre (L)

Measure	itraconazole + BI 1015550 (T) n = 16	BI 1015550 alone (R) n = 16
Value	2073.40 (NA)	933.44 (NA)

itraconazole + BI 1015550 (T) vs BI 1015550 alone (R): Geometric Mean (T/R) ratio (%): 222.13 (90% CI 203.47 to 242.49)

Population analysed: Pharmacokinetic (PK) set (PKS): The PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was not excluded. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment.

Primary outcome: Maximum Measured Concentration of the BI 1015550 in Plasma

Time frame: Up to 215 hours (Please check measure description for detailed timeframe). Geometric mean (Standard Error). Unit: nmol/L

Measure	itraconazole + BI 1015550 (T) n = 16	BI 1015550 alone (R) n = 16
Value	162.39 (NA)	126.91 (NA)

itraconazole + BI 1015550 (T) vs BI 1015550 alone (R): Geometric Mean (T/R) ratio (%): 127.96 (90% CI 117.65 to 139.17)

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1015550	0 of 16 (0%)	5 of 16 (31.3%)	0 of 16
itraconazole	0 of 16 (0%)	5 of 16 (31.3%)	0 of 16
itraconazole + BI 1015550	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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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 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 13 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 28 Nov 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 28 Nov 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 BI 1015550 in Plasma Over the Time Interval From 0 to 119 Hours (time frame: Up to 215 hours (Please check measure description for detailed timeframe)). 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 NCT03403439.

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 28 Nov 2025; AzTrials last refreshed its copy on 4 Nov 2026.