Trial Outcomes & Findings for A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body (NCT NCT05633862)
NCT ID: NCT05633862
Last Updated: 2025-11-28
Results Overview
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.
Results posted on
2025-11-28
Participant Flow
This was a non-randomised, uncontrolled, open label, single-dose, parallel-group design trial.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 1015550 9 mg
A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
BI 1015550 18 mg
A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body
Baseline characteristics by cohort
| Measure |
BI 1015550 9 mg
n=12 Participants
A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
BI 1015550 18 mg
n=12 Participants
A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 4.9 • n=30 Participants
|
29.8 years
STANDARD_DEVIATION 1.9 • n=30 Participants
|
33.3 years
STANDARD_DEVIATION 5.0 • n=60 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
13 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
12 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Korean
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Southeast Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Taiwanese
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of trial and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
BI 1015550 9 mg
n=12 Participants
A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
BI 1015550 18 mg
n=12 Participants
A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
1780 Nanomol*Hour/Liter
Geometric Coefficient of Variation 19.1
|
3680 Nanomol*Hour/Liter
Geometric Coefficient of Variation 32.6
|
PRIMARY outcome
Timeframe: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of trial and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 1015550 in plasma (Cmax).
Outcome measures
| Measure |
BI 1015550 9 mg
n=12 Participants
A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
BI 1015550 18 mg
n=12 Participants
A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
|
325 Nanomol/Liter
Geometric Coefficient of Variation 30.3
|
591 Nanomol/Liter
Geometric Coefficient of Variation 39.0
|
SECONDARY outcome
Timeframe: Up to 7 days.Population: Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
Number of subjects with any treatment-emergent adverse event (AE).
Outcome measures
| Measure |
BI 1015550 9 mg
n=12 Participants
A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
BI 1015550 18 mg
n=12 Participants
A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Number of Subjects With Any Treatment-emergent Adverse Event (AE)
|
2 Participants
|
6 Participants
|
Adverse Events
BI 1015550 9 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1015550 18 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1015550 9 mg
n=12 participants at risk
A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
BI 1015550 18 mg
n=12 participants at risk
A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Investigations
White blood cells urine positive
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
16.7%
2/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
16.7%
2/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
Basophil count increased
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
C-reactive protein increased
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Investigations
Urinary occult blood positive
|
8.3%
1/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one 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