HealthyPhase 1NCT01835899

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

A Phase 1 study testing BI 1015550 and BI1015550 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

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1015550 and BI1015550
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteGermany
Study dates: Apr 2013to Jun 2013
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy male subjects

Who cannot join

Any relevant deviation from healthy conditions
Subjects unable to understand or to comply with study requirements

Trial locations and contacts

1 site in 1 country.

Germany1 site

1305.2.1 Boehringer Ingelheim Investigational Site
Mannheim

Other trials in Germany

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Conditions: Healthy
Being tested: Placebo, BI 1015550, BI1015550

What participants receive

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

PlaceboDrug
Placebo to BI 1015550
BI 1015550Drug
medium dose 1 powder for oral solution
BI 1015550Drug
medium dose 2 powder for oral solution
BI1015550Drug
low dose 2 powder for oral solution
BI 1015550Drug
low dose 1 powder for oral solution

Study groups in NCT01835899
Study group	Role	What they receive
Placebo to BI 1015550	Experimental	placebo Receives: Drug: Placebo
BI 1015550 low dose 1	Experimental	powder for oral solution Receives: Drug: BI 1015550
BI 1015550 low dose 2	Experimental	powder for oral solution Receives: Drug: BI1015550
BI 1015550 medium dose 1	Experimental	powder for oral solution Receives: Drug: BI 1015550
BI 1015550 medium dose 2	Experimental	powder for oral solution Receives: Drug: BI 1015550

What is being measured

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

Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug related Adverse events, as assessed by the investigator.
Measured: From first drug administration until last drug administration, upto 18 days.

Secondary outcomes (5)

Cmax
Maximum measured concentration of BI 1015550 in plasma.
Measured: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
AUCt,1
Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose
Measured: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration
AUC0-infinity
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.
Measured: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
Cmax,ss
Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.
Measured: 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.
AUCt,ss
Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.
Measured: 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.

Timeline

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

Apr 2013Jun 2013

First posted19 Apr 2013 (estimated)
Study startApr 2013
Primary completionJun 2013
Study completionJun 2013

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.
Publications (1)Papers the sponsor has linked to this study.
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: Parallel groups
Masking: Double blind
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01835899
Sponsor's protocol ID: 1305.2
Other IDs: 2012-005614-19
Status last verified: Dec 2015
First submitted: 9 Apr 2013
Last updated: 22 Jan 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Jappar D, Wu J, Burkard U, Sharma A, Coeck C, Zoz D, Yu Y. Pharmacokinetics and Safety of Nerandomilast in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2026 Aug 6. doi: 10.1007/s13318-026-01027-9. Online ahead of print.
PubMed 42563128

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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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
ClinicalTrials.gov ID: NCT01835899
Acronym / sponsor ID: 1305.2
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 19 Apr 2013 (estimated)
Results: Posted 22 Jan 2016

Clinical summary

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

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
Placebo to BI 1015550	Experimental	Drug: Placeboplacebo
BI 1015550 low dose 1	Experimental	Drug: BI 1015550powder for oral solution
BI 1015550 low dose 2	Experimental	Drug: BI1015550powder for oral solution
BI 1015550 medium dose 1	Experimental	Drug: BI 1015550powder for oral solution
BI 1015550 medium dose 2	Experimental	Drug: BI 1015550powder for oral solution

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male subjects

Key exclusion criteria (2 listed)

Any relevant deviation from healthy conditions
Subjects unable to understand or to comply with study requirements

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
PlaceboPlacebo to BI 1015550	Drug	Placebo to BI 1015550
BI 1015550medium dose 1 powder for oral solution	Drug	BI 1015550 medium dose 1
BI 1015550medium dose 2 powder for oral solution	Drug	BI 1015550 medium dose 2
BI1015550low dose 2 powder for oral solution	Drug	BI 1015550 low dose 2
BI 1015550low dose 1 powder for oral solution	Drug	BI 1015550 low dose 1

Primary outcome

Percentage of Subjects With Drug-related Adverse Events
Time frame: From first drug administration until last drug administration, upto 18 days.
Percentage of subjects with drug related Adverse events, as assessed by the investigator.

5 secondary outcomes

Cmax
Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
AUCt,1
Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration
AUC0-infinity
Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
Cmax,ss
Time frame: 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.
AUCt,ss
Time frame: 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.

Results and safety

Results posted to the registry on 22 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo to BI 1015550	6	6
1 mg BI 1015550	9	8
6 mg BI 1015550	9	8

Primary outcome: Percentage of Subjects With Drug-related Adverse Events

Time frame: From first drug administration until last drug administration, upto 18 days.. Number. Unit: Percentage of participants

Measure	Placebo to BI 1015550 n = 6	1 mg BI 1015550 n = 9	6 mg BI 1015550 n = 9
Value	16.7	44.4	11.1

Population analysed: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until last drug administration, upto 18 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo to BI 1015550	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
1 mg BI 1015550	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
6 mg BI 1015550	0 of 9 (0%)	1 of 9 (11.1%)	Not reported

Limitations and caveats (from the sponsor): The study was prematurely completed as per protocol after 2 of the originally planned 4 dose groups ie., 1 mg BI 1015550 and 6 mg BI 1015550 because of higher than expected drug exposure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42563128Jappar D, Wu J, Burkard U, Sharma A, Coeck C, Zoz D, Yu Y. Pharmacokinetics and Safety of Nerandomilast in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2026 Aug 6. doi: 10.1007/s13318-026-01027-9. Online ahead of print.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 BI1015550 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 1 inclusion and 2 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 22 Jan 2016. 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 22 Jan 2016). 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?

Percentage of Subjects With Drug-related Adverse Events (time frame: From first drug administration until last drug administration, upto 18 days.). 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 NCT01835899, which also lists 1 linked publication.

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 22 Jan 2016.