HealthyPhase 1NCT01594515

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

A Phase 1 study testing BI 1015550 and BI 101550 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

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1015550 and BI 101550
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteGermany
Study dates: May 2012to Sep 2012
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy male subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1305.1.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Conditions: Healthy
Being tested: BI 1015550, Placebo, BI 101550

What participants receive

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

BI 1015550Drug
High dose powder for oral solution
BI 1015550Drug
Medium dose powder for oral solution
BI 1015550Drug
Low dose powder for oral solution
BI 1015550Drug
Low dose powder for oral solution
BI 1015550Drug
Low dose powder for oral solution
PlaceboDrug
Solution for oral administration
BI 101550Drug
High dose powder for oral solution
BI 1015550Drug
Low dose powder for oral solution
BI 1015550Drug
Medium dose powder for oral solution
BI 1015550Drug
Medium dose powder for oral solution

Study groups in NCT01594515
Study group	Role	What they receive
BI 1015550 low dose A	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 low dose B	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 low dose C	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 low dose D	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 medium dose A	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 medium dose B	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 medium dose C	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 high dose A	Experimental	Powder for oral solution Receives: Drug: BI 1015550
BI 1015550 high dose B	Experimental	Powder for oral solution Receives: Drug: BI 101550
Placebo	Placebo comparator	Solution for oral administration Receives: Drug: Placebo

What is being measured

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

Number (%) of Subjects With Drug Related Adverse Events
Percentage of subjects with drug related adverse events.
Measured: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests
Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).
Measured: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs
Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).
Measured: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs
Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.
Measured: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability
Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.
Measured: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations
Percentage of subjects with clinically relevant abnormalities in physical examinations.
Measured: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.

Secondary outcomes (2)

Cmax of BI 1015550
Maximum measured concentration of the analyte in plasma.
Measured: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
AUC0-infinity of BI 1015550
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
Measured: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

Timeline

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

May 2012Sep 2012

First posted9 May 2012 (estimated)
Study startMay 2012
Primary completionSep 2012
Study completionSep 2012

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: Single blind
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01594515
Sponsor's protocol ID: 1305.1
Other IDs: 2012-000405-68
Status last verified: Nov 2015
First submitted: 7 May 2012
Last updated: 15 Dec 2015
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?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)
ClinicalTrials.gov ID: NCT01594515
Acronym / sponsor ID: 1305.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 9 May 2012 (estimated)
Results: Posted 15 Dec 2015

Clinical summary

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

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Number of arms: 10

Arm	Type	Receives
BI 1015550 low dose A	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 low dose B	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 low dose C	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 low dose D	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 medium dose A	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 medium dose B	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 medium dose C	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 high dose A	Experimental	Drug: BI 1015550Powder for oral solution
BI 1015550 high dose B	Experimental	Drug: BI 101550Powder for oral solution
Placebo	Placebo comparator	Drug: PlaceboSolution for oral administration

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male subjects

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

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 1015550High dose powder for oral solution	Drug	BI 1015550 high dose A
BI 1015550Medium dose powder for oral solution	Drug	BI 1015550 medium dose A
BI 1015550Low dose powder for oral solution	Drug	BI 1015550 low dose C
BI 1015550Low dose powder for oral solution	Drug	BI 1015550 low dose B
BI 1015550Low dose powder for oral solution	Drug	BI 1015550 low dose A
PlaceboSolution for oral administration	Drug	Placebo
BI 101550High dose powder for oral solution	Drug	BI 1015550 high dose B
BI 1015550Low dose powder for oral solution	Drug	BI 1015550 low dose D
BI 1015550Medium dose powder for oral solution	Drug	BI 1015550 medium dose C
BI 1015550Medium dose powder for oral solution	Drug	BI 1015550 medium dose B

Primary outcome

Number (%) of Subjects With Drug Related Adverse Events
Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Percentage of subjects with drug related adverse events.
Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests
Time frame: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).
Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs
Time frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).
Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs
Time frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.
Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability
Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.
Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations
Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Percentage of subjects with clinically relevant abnormalities in physical examinations.

2 secondary outcomes

Cmax of BI 1015550
Time frame: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
AUC0-infinity of BI 1015550
Time frame: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing

Results and safety

Results posted to the registry on 15 Dec 2015, 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 Low Dose 0.02mg	6	6
BI 1015550 Low Dose 0.06mg	6	6
BI 1015550 Low Dose 0.2mg	6	6
BI 1015550 Low Dose 0.6mg	6	6
BI 1015550 Medium Dose 2mg	6	6
BI 1015550 Medium Dose 4mg	6	6
BI 1015550 Medium Dose 8mg	6	6
BI 1015550 High Dose 16mg	6	6
BI 1015550 High Dose 24mg	6	6
Placebo	16	16

Primary outcome: Number (%) of Subjects With Drug Related Adverse Events

Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.. Number. Unit: Percentage of Participants

Measure	BI 1015550 Low Dose 0.02mg n = 6	BI 1015550 Low Dose 0.06mg n = 6	BI 1015550 Low Dose 0.2mg n = 6	BI 1015550 Low Dose 0.6mg n = 6	BI 1015550 Medium Dose 2mg n = 6	BI 1015550 Medium Dose 4mg n = 6	BI 1015550 Medium Dose 8mg n = 6	BI 1015550 High Dose 16mg n = 6	BI 1015550 High Dose 24mg n = 6	Placebo n = 16
Value	0.0	33.3	16.7	0.0	0.0	33.3	16.7	16.7	16.7	6.3

Population analysed: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.

Primary outcome: Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests

Time frame: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).. Number. Unit: Percentage of Participants

Measure	BI 1015550 Low Dose 0.02mg n = 6	BI 1015550 Low Dose 0.06mg n = 6	BI 1015550 Low Dose 0.2mg n = 6	BI 1015550 Low Dose 0.6mg n = 6	BI 1015550 Medium Dose 2mg n = 6	BI 1015550 Medium Dose 4mg n = 6	BI 1015550 Medium Dose 8mg n = 6	BI 1015550 High Dose 16mg n = 6	BI 1015550 High Dose 24mg n = 6	Placebo n = 16
Value	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Population analysed: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.

Primary outcome: Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs

Time frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).. Number. Unit: Percentage of Participants

Measure	BI 1015550 Low Dose 0.02mg n = 6	BI 1015550 Low Dose 0.06mg n = 6	BI 1015550 Low Dose 0.2mg n = 6	BI 1015550 Low Dose 0.6mg n = 6	BI 1015550 Medium Dose 2mg n = 6	BI 1015550 Medium Dose 4mg n = 6	BI 1015550 Medium Dose 8mg n = 6	BI 1015550 High Dose 16mg n = 6	BI 1015550 High Dose 24mg n = 6	Placebo n = 16
Value	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Population analysed: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.

Primary outcome: Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs

Time frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).. Number. Unit: Percentage of Participants

Measure	BI 1015550 Low Dose 0.02mg n = 6	BI 1015550 Low Dose 0.06mg n = 6	BI 1015550 Low Dose 0.2mg n = 6	BI 1015550 Low Dose 0.6mg n = 6	BI 1015550 Medium Dose 2mg n = 6	BI 1015550 Medium Dose 4mg n = 6	BI 1015550 Medium Dose 8mg n = 6	BI 1015550 High Dose 16mg n = 6	BI 1015550 High Dose 24mg n = 6	Placebo n = 16
Value	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0

Population analysed: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	5 of 16 (31.3%)	Not reported
BI 1015550 Low Dose 0.02mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
BI 1015550 Low Dose 0.06mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
BI 1015550 Low Dose 0.2mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
BI 1015550 Low Dose 0.6mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
BI 1015550 Medium Dose 2mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
BI 1015550 Medium Dose 4mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
BI 1015550 Medium Dose 8mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
BI 1015550 High Dose 16mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
BI 1015550 High Dose 24mg	0 of 6 (0%)	3 of 6 (50%)	Not reported

Limitations and caveats (from the sponsor): BI 1015550 high dose 24mg was originally planned as 26 mg but reduced due to PK interim analysis results of previous dose group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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.
Related InfoLink provided by the sponsor.

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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 BI 101550 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 1 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 15 Dec 2015. 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. Some participants in this study may receive a placebo. 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 15 Dec 2015). 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?

Number (%) of Subjects With Drug Related Adverse Events (time frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.). The study lists 6 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 NCT01594515, 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 15 Dec 2015.