Trial Outcomes & Findings for This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 1015550 Are Taken up in the Body and How Well They Are Tolerated. (NCT NCT03542344)
NCT ID: NCT03542344
Last Updated: 2025-11-28
Results Overview
Number of participants with drug-related adverse events is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
From drug administration until end of study, up to 9 days
Results posted on
2025-11-28
Participant Flow
This randomized, parallel, placebo-controlled and double-blind trial tested single dose of BI 1015550 in 2 rising dose groups (12 and 24 mg). Subjects stayed in-house for 2 days (d) after single oral dose of trial drug and the end of trial examination took place 7 to 8 d after trial drug administration.
All subjects were screened for eligibility to participants in the trial. Subjects attended specialist sites which would then ensure that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Placebo
Comparator product: Matching placebo. The medication was administrated orally with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours. 2 subjects from BI 1015550 12 milligram (mg) arm and 2 subjects from BI 1015550 24mg arm taking Placebo are combined.
|
BI 1015550 12mg
2 film-coated tablets with 6mg of BI 1015550 each (12mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
BI 1015550 24mg
4 film-coated tablets with 6mg of BI 1015550 each (24mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study is Done in Healthy Japanese Volunteers. It Looks at How Different Doses of BI 1015550 Are Taken up in the Body and How Well They Are Tolerated.
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Comparator product: Matching placebo. The medication was administrated orally with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours. 2 subjects from BI 1015550 12 milligram (mg) arm and 2 subjects from BI 1015550 24mg arm taking Placebo are combined.
|
BI 1015550 12mg
n=6 Participants
2 film-coated tablets with 6mg of BI 1015550 each (12mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
BI 1015550 24mg
n=6 Participants
4 film-coated tablets with 6mg of BI 1015550 each (24mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
16 Participants
n=92 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Age, Continuous
|
27.5 Years
STANDARD_DEVIATION 4.7 • n=30 Participants
|
32.8 Years
STANDARD_DEVIATION 9.3 • n=30 Participants
|
28.7 Years
STANDARD_DEVIATION 8.3 • n=60 Participants
|
29.9 Years
STANDARD_DEVIATION 7.8 • n=92 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
16 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
16 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=92 Participants
|
PRIMARY outcome
Timeframe: From drug administration until end of study, up to 9 daysPopulation: Treated set (TS): This subject set included data from all subjects who received at least 1 dose of trial drug.
Number of participants with drug-related adverse events is presented.
Outcome measures
| Measure |
Placebo
n=4 Participants
Comparator product: Matching placebo. The medication was administrated orally with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours. 2 subjects from BI 1015550 12 milligram (mg) arm and 2 subjects from BI 1015550 24mg arm taking Placebo are combined.
|
BI 1015550 12mg
n=6 Participants
2 film-coated tablets with 6mg of BI 1015550 each (12mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
BI 1015550 24mg
n=6 Participants
4 film-coated tablets with 6mg of BI 1015550 each (24mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Number of Participants With Drug-related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 hours after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This subject set included data from all subjects from the TS who provided at least 1 secondary pharmacokinetic endpoint (AUC0-inf or Cmax) that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability.
Area under the concentration-time curve of the BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is presented.
Outcome measures
| Measure |
Placebo
n=6 Participants
Comparator product: Matching placebo. The medication was administrated orally with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours. 2 subjects from BI 1015550 12 milligram (mg) arm and 2 subjects from BI 1015550 24mg arm taking Placebo are combined.
|
BI 1015550 12mg
n=6 Participants
2 film-coated tablets with 6mg of BI 1015550 each (12mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
BI 1015550 24mg
4 film-coated tablets with 6mg of BI 1015550 each (24mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
2410 nanomole*hours per Litre (nmol*h/L)
Geometric Coefficient of Variation 20.8
|
5760 nanomole*hours per Litre (nmol*h/L)
Geometric Coefficient of Variation 21.6
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 hours after drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This subject set included data from all subjects from the TS who provided at least 1 secondary pharmacokinetic endpoint (AUC0-inf or Cmax) that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability.
Maximum measured concentration of the BI 1015550 in plasma (Cmax) is presented.
Outcome measures
| Measure |
Placebo
n=6 Participants
Comparator product: Matching placebo. The medication was administrated orally with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours. 2 subjects from BI 1015550 12 milligram (mg) arm and 2 subjects from BI 1015550 24mg arm taking Placebo are combined.
|
BI 1015550 12mg
n=6 Participants
2 film-coated tablets with 6mg of BI 1015550 each (12mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
BI 1015550 24mg
4 film-coated tablets with 6mg of BI 1015550 each (24mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|
|
Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax)
|
449 nanomole per Litre (nmol/L)
Geometric Coefficient of Variation 19.1
|
944 nanomole per Litre (nmol/L)
Geometric Coefficient of Variation 43.5
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1015550 12mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 1015550 24mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 1015550 Total
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Comparator product: Matching placebo. The medication was administrated orally with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours. 2 subjects from BI 1015550 12 milligram (mg) arm and 2 subjects from BI 1015550 24mg arm taking Placebo are combined.
|
BI 1015550 12mg
n=6 participants at risk
2 film-coated tablets with 6mg of BI 1015550 each (12mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
BI 1015550 24mg
n=6 participants at risk
4 film-coated tablets with 6mg of BI 1015550 each (24mg total) were administrated as single oral dose with about 240 mL of water after an overnight fast of at least 10 hours.
|
BI 1015550 Total
n=12 participants at risk
The group consists of 6 participants from BI 1015550 12mg arm and 6 participants from BI 1015550 24mg arm taking trial medication.
|
|---|---|---|---|---|
|
Investigations
Occult blood positive
|
25.0%
1/4 • "All-Cause Mortality", "Serious Adverse Events" and "Other Adverse Events": From first drug administration until end-of-study examination, up to 9 days.
Treated set (TS): This subject set included data from all subjects who received at least 1 dose of trial drug.
|
0.00%
0/6 • "All-Cause Mortality", "Serious Adverse Events" and "Other Adverse Events": From first drug administration until end-of-study examination, up to 9 days.
Treated set (TS): This subject set included data from all subjects who received at least 1 dose of trial drug.
|
0.00%
0/6 • "All-Cause Mortality", "Serious Adverse Events" and "Other Adverse Events": From first drug administration until end-of-study examination, up to 9 days.
Treated set (TS): This subject set included data from all subjects who received at least 1 dose of trial drug.
|
0.00%
0/12 • "All-Cause Mortality", "Serious Adverse Events" and "Other Adverse Events": From first drug administration until end-of-study examination, up to 9 days.
Treated set (TS): This subject set included data from all subjects who received at least 1 dose of trial drug.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER