Trial Outcomes & Findings for A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food (NCT NCT05428436)
NCT ID: NCT05428436
Last Updated: 2025-12-19
Results Overview
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).
COMPLETED
PHASE1
24 participants
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, 144 hours following drug administration.
2025-12-19
Participant Flow
The trial was a randomised, open-label, single-dose, three-way crossover design. The subjects were randomly allocated to 1 of 3 treatment sequences. Each subject participated in 3 treatment periods, receiving a single dose in each, with a washout period of at least 7 days between treatments.
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 |
R/T1/T2
Three period crossover with treatments in the following order:
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Periods were separated by a washout period of at least 7 days between treatments.
|
T1/T2/R
Three period crossover with treatments in the following order:
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Periods were separated by a washout period of at least 7 days between treatments.
|
T2/R/T1
Three period crossover with treatments in the following order:
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Periods were separated by a washout period of at least 7 days between treatments
|
|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
8
|
|
Period 1
COMPLETED
|
8
|
8
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 1 - 2 washout
STARTED
|
8
|
8
|
8
|
|
Period 1 - 2 washout
COMPLETED
|
7
|
8
|
8
|
|
Period 1 - 2 washout
NOT COMPLETED
|
1
|
0
|
0
|
|
Period 2
STARTED
|
7
|
8
|
8
|
|
Period 2
COMPLETED
|
7
|
8
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2 - 3 washout
STARTED
|
7
|
8
|
8
|
|
Period 2 - 3 washout
COMPLETED
|
7
|
8
|
8
|
|
Period 2 - 3 washout
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 3
STARTED
|
7
|
8
|
8
|
|
Period 3
COMPLETED
|
7
|
8
|
8
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
R/T1/T2
Three period crossover with treatments in the following order:
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Periods were separated by a washout period of at least 7 days between treatments.
|
T1/T2/R
Three period crossover with treatments in the following order:
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Periods were separated by a washout period of at least 7 days between treatments.
|
T2/R/T1
Three period crossover with treatments in the following order:
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Periods were separated by a washout period of at least 7 days between treatments
|
|---|---|---|---|
|
Period 1 - 2 washout
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food
Baseline characteristics by cohort
| Measure |
R/T1/T2
n=8 Participants
Three period crossover with treatments in the following order:
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Periods were separated by a washout period of at least 7 days between treatments.
|
T1/T2/R
n=8 Participants
Three period crossover with treatments in the following order:
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Periods were separated by a washout period of at least 7 days between treatments.
|
T2/R/T1
n=8 Participants
Three period crossover with treatments in the following order:
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Periods were separated by a washout period of at least 7 days between treatments
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 11.3 • n=8 Participants
|
40.0 years
STANDARD_DEVIATION 11.8 • n=6 Participants
|
39.6 years
STANDARD_DEVIATION 14.2 • n=6 Participants
|
39.4 years
STANDARD_DEVIATION 11.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=8 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=8 Participants
|
8 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
23 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=8 Participants
|
8 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 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, 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects who were treated with at least one dose of trial drug and who provided at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary 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 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
Reference treatment (R) - fasted
n=24 Participants
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 1 (T1) - fasted
n=23 Participants
Test treatment 1 (T1): one 18 milligram BI 1015550-film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 2 (T2) - fed
n=23 Participants
Test treatment 2 (T2): one 18 milligram BI 1015550 film--coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
|
|---|---|---|---|
|
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)
|
2290 hours*nanomol/Liter
Geometric Coefficient of Variation 194
|
2740 hours*nanomol/Liter
Geometric Coefficient of Variation 34.7
|
3000 hours*nanomol/Liter
Geometric Coefficient of Variation 31.2
|
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, 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects who were treated with at least one dose of trial drug and who provided at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary 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 R-BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The endpoint was analyzed additionally for the chirally pure (R) form of BI 1015550 (R-BI 1015550, the pharmacologically active form).
Outcome measures
| Measure |
Reference treatment (R) - fasted
n=24 Participants
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 1 (T1) - fasted
n=23 Participants
Test treatment 1 (T1): one 18 milligram BI 1015550-film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 2 (T2) - fed
n=23 Participants
Test treatment 2 (T2): one 18 milligram BI 1015550 film--coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
1900 hours*nanomol/Liter
Geometric Coefficient of Variation 197
|
2310 hours*nanomol/Liter
Geometric Coefficient of Variation 29.6
|
2500 hours*nanomol/Liter
Geometric Coefficient of Variation 26.9
|
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, 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects who were treated with at least one dose of trial drug and who provided at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary 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 |
Reference treatment (R) - fasted
n=24 Participants
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 1 (T1) - fasted
n=23 Participants
Test treatment 1 (T1): one 18 milligram BI 1015550-film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 2 (T2) - fed
n=23 Participants
Test treatment 2 (T2): one 18 milligram BI 1015550 film--coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
|
|---|---|---|---|
|
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
|
313 nanomol/Liter
Geometric Coefficient of Variation 165
|
364 nanomol/Liter
Geometric Coefficient of Variation 36.6
|
323 nanomol/Liter
Geometric Coefficient of Variation 22.7
|
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, 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects who were treated with at least one dose of trial drug and who provided at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary 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 R-BI 1015550 in plasma (Cmax). The endpoint was analyzed additionally for the chirally pure (R) form of BI 1015550 (R-BI 1015550, the pharmacologically active form).
Outcome measures
| Measure |
Reference treatment (R) - fasted
n=24 Participants
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 1 (T1) - fasted
n=23 Participants
Test treatment 1 (T1): one 18 milligram BI 1015550-film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 2 (T2) - fed
n=23 Participants
Test treatment 2 (T2): one 18 milligram BI 1015550 film--coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
|
|---|---|---|---|
|
Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax)
|
307 nanomol/Liter
Geometric Coefficient of Variation 166
|
352 nanomol/Liter
Geometric Coefficient of Variation 35.4
|
319 nanomol/Liter
Geometric Coefficient of Variation 23.8
|
SECONDARY 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, 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects who were treated with at least one dose of trial drug and who provided at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Endpoint only includes subjects where AUC0-∞,pred could be calculated.
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity, predicted (AUC0-∞,pred).
Outcome measures
| Measure |
Reference treatment (R) - fasted
n=23 Participants
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 1 (T1) - fasted
n=23 Participants
Test treatment 1 (T1): one 18 milligram BI 1015550-film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 2 (T2) - fed
n=23 Participants
Test treatment 2 (T2): one 18 milligram BI 1015550 film--coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Predicted (AUC0-∞,Pred)
|
2970 hours*nanomol/Liter
Geometric Coefficient of Variation 30.0
|
2780 hours*nanomol/Liter
Geometric Coefficient of Variation 35.1
|
3050 hours*nanomol/Liter
Geometric Coefficient of Variation 31.7
|
SECONDARY 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, 144 hours following drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects who were treated with at least one dose of trial drug and who provided at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Endpoint only includes subjects where AUC0-∞,pred could be calculated.
Area under the concentration-time curve of R-BI 1015550 in plasma over the time interval from 0 extrapolated to infinity, predicted (AUC0-∞,pred). The endpoint was analyzed additionally for the chirally pure (R) form of BI 1015550 (R-BI 1015550, the pharmacologically active form).
Outcome measures
| Measure |
Reference treatment (R) - fasted
n=23 Participants
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 1 (T1) - fasted
n=23 Participants
Test treatment 1 (T1): one 18 milligram BI 1015550-film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
|
Test treatment 2 (T2) - fed
n=23 Participants
Test treatment 2 (T2): one 18 milligram BI 1015550 film--coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Predicted (AUC0-∞,Pred)
|
2460 hours*nanomol/Liter
Geometric Coefficient of Variation 27.0
|
2340 hours*nanomol/Liter
Geometric Coefficient of Variation 30.0
|
2530 hours*nanomol/Liter
Geometric Coefficient of Variation 27.2
|
Adverse Events
Reference Treatment (R) - Fasted
Test Treatment 1 (T1) - Fasted
Test Treatment 2 (T2) - Fed
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference Treatment (R) - Fasted
n=24 participants at risk
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
|
Test Treatment 1 (T1) - Fasted
n=23 participants at risk
Test treatment 1 (T1): one 18 milligram BI 1015550-film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
|
Test Treatment 2 (T2) - Fed
n=23 participants at risk
Test treatment 2 (T2): one 18 milligram BI 1015550 film--coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
20.8%
5/24 • Adverse events: From trial medication intake till the end of the residual effect period (REP), 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.
|
13.0%
3/23 • Adverse events: From trial medication intake till the end of the residual effect period (REP), 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.
|
8.7%
2/23 • Adverse events: From trial medication intake till the end of the residual effect period (REP), 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place