HealthyPhase 1NCT03302078

Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects

A Phase 1 study testing BI 1015550 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.

Trial summary

The primary objective of this trial is to investigate the effect of food on the pharmacokinetics of the oral tablet formulation of BI 1015550 by investigating the relative bioavailability of TF1 under fed and fasted conditions. The assessment of safety and tolerability will be an additional objective of this part. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteGermany
Study dates: 16 Oct 2017to 13 Dec 2017
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 (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), 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 Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) 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
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)

Show all 23Show 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 signs of suicidality (ideation as well as behavior) in the past
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)
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
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on trial days
Alcohol abuse (consumption of more than 30 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant Electrocardiogram (ECG) finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device, hormonal contraceptive since at least two month)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

The assessment of safety and tolerability will be an additional objective of this part.

Conditions: Healthy
Being tested: BI 1015550

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 4x6 mg (24 mg) tablets under fed or fasted condition

Study groups in NCT03302078
Study group	Role	What they receive
BI 1015550 24 milligrams (mg) fed / BI 1015550 24 mg fast	Experimental	Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fed condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fasted condition, each treatment with 240 milliliter (mL) water, separated by a wash-out period of at least 7 days between drug administrations. Receives: Drug: BI 1015550
BI 1015550 24 mg fast / BI 1015550 24 mg fed	Experimental	Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fasted condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fed condition, each treatment with 240 mL water, separated by a wash-out period of at least 7 days between drug administrations. Receives: Drug: BI 1015550

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 the Last Quantifiable Data Point (AUC0-tz)
AUC0-tz, area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
Measured: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
Cmax, maximum measured concentration of BI 1015550 in plasma. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
Measured: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.

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)
AUC0-inf, area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
Measured: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.

Timeline

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

16 Oct 201713 Dec 2017

First posted4 Oct 2017
Study start16 Oct 2017
Primary completion13 Dec 2017
Study completion13 Dec 2017

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03302078
Sponsor's protocol ID: 1305-0020
Other IDs: 2017-002271-26, 2017
Status last verified: Oct 2025
First submitted: 28 Sep 2017
Last updated: 28 Nov 2025
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?

See locations

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All Healthy trials

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 BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03302078
Acronym / sponsor ID: 1305-0020
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 16 Oct 2017 (actual)
Primary completion: 13 Dec 2017 (actual)
Study completion: 13 Dec 2017 (actual)
First posted: 4 Oct 2017 (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.

The assessment of safety and tolerability will be an additional objective of this part.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI 1015550 24 milligrams (mg) fed / BI 1015550 24 mg fast	Experimental	Drug: BI 1015550Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fed condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fasted condition, each treatment with 240 milliliter (mL) water, separated by a wash-out period of at least 7 days between drug administrations.
BI 1015550 24 mg fast / BI 1015550 24 mg fed	Experimental	Drug: BI 1015550Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fasted condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fed condition, each treatment with 240 mL water, separated by a wash-out period of at least 7 days between drug administrations.

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 (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), 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 (23 listed)

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) 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
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 4x6 mg (24 mg) tablets under fed or fasted condition	Drug	BI 1015550 24 mg fast / BI 1015550 24 mg fed, BI 1015550 24 milligrams (mg) fed / BI 1015550 24 mg fast

Primary outcome

Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.
AUC0-tz, area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
Time frame: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.
Cmax, maximum measured concentration of BI 1015550 in plasma. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.

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: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.

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 24 milligrams (mg) fed / BI 1015550 24 mg fast	6	6
BI 1015550 24 mg fast / BI 1015550 24 mg fed	6	6

Primary outcome: Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.. Geometric least squares mean (Standard Error). Unit: nanomole*hours/Liter (nmol*h/L)

Measure	BI 1015550 24 mg fed (Test, T) n = 11	BI 1015550 24 mg fast (Reference, R) n = 12
Value	4164.32 (NA)	4057.42 (NA)

BI 1015550 24 mg fed (Test, T) vs BI 1015550 24 mg fast (Reference, R): Geometric Mean (T/R) ratio (%): 102.63 (90% CI 98.31 to 107.15)

Population analysed: Pharmacokinetic (PK) set (PKS):The PKS included all subjects in the Treated Set (TS) who provided at least one primary or secondary PK parameter that was not excluded due to important protocol violations relevant to the evaluation of PK or due to PK non-evaluability.

Primary outcome: Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)

Measure	BI 1015550 24 mg fed (Test, T) n = 11	BI 1015550 24 mg fast (Reference, R) n = 12
Value	404.34 (NA)	511.29 (NA)

BI 1015550 24 mg fed (Test, T) vs BI 1015550 24 mg fast (Reference, R): Geometric Mean (T/R) ratio (%): 79.08 (90% CI 69.96 to 89.40)

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1015550 24 mg fed (Test, T)	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
BI 1015550 24 mg fast (Reference, R)	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Total on treatment	0 of 12 (0%)	6 of 12 (50%)	0 of 12

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: 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 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 23 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 the Last Quantifiable Data Point (AUC0-tz) (time frame: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 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, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.). 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 NCT03302078.

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.