Trial Outcomes & Findings for Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects (NCT NCT03302078)
NCT ID: NCT03302078
Last Updated: 2025-11-28
Results Overview
AUC0-tz, area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
COMPLETED
PHASE1
12 participants
Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.
2025-11-28
Participant Flow
This was a phase I, open-label, randomised, single dose, two-period, two-sequence crossover trial performed in healthy subjects.
All participants were screened for eligibility to participate in the trial. Participants attended specialist site which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria were not met
Participant milestones
| Measure |
BI 1015550 24 milligrams (mg) fed / BI 1015550 24 mg fast
Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fed condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fasted condition, each treatment with 240 milliliter (mL) water, separated by a wash-out period of at least 7 days between drug administrations.
|
BI 1015550 24 mg fast / BI 1015550 24 mg fed
Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fasted condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fed condition, each treatment with 240 mL water, separated by a wash-out period of at least 7 days between drug administrations.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
6
|
6
|
|
Treatment Period 1
COMPLETED
|
6
|
6
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
6
|
6
|
|
Washout Period
COMPLETED
|
6
|
5
|
|
Washout Period
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2
STARTED
|
6
|
5
|
|
Treatment Period 2
COMPLETED
|
6
|
5
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
BI 1015550 24 milligrams (mg) fed / BI 1015550 24 mg fast
Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fed condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fasted condition, each treatment with 240 milliliter (mL) water, separated by a wash-out period of at least 7 days between drug administrations.
|
BI 1015550 24 mg fast / BI 1015550 24 mg fed
Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fasted condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fed condition, each treatment with 240 mL water, separated by a wash-out period of at least 7 days between drug administrations.
|
|---|---|---|
|
Washout Period
Adverse Event
|
0
|
1
|
Baseline Characteristics
Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
BI 1015550 24 Milligrams (mg) Fed / BI 1015550 24 mg Fast
n=6 Participants
Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fed condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fasted condition, each treatment with 240 milliliter (mL) water, separated by a wash-out period of at least 7 days between drug administrations.
|
BI 1015550 24 mg Fast / BI 1015550 24 mg Fed
n=6 Participants
Subjects were treated orally in period 1 with single dose of BI 1015550 4x6 mg (24 mg) tablets under fasted condition, followed in period 2 with 4x6 mg (24 mg) of BI 1015550 tablets under fed condition, each treatment with 240 mL water, separated by a wash-out period of at least 7 days between drug administrations.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 Years
STANDARD_DEVIATION 8.1 • n=30 Participants
|
40.5 Years
STANDARD_DEVIATION 13.1 • n=30 Participants
|
43.3 Years
STANDARD_DEVIATION 10.8 • n=60 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
12 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
|
6 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
12 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
12 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.Population: Pharmacokinetic (PK) set (PKS):The PKS included all subjects in the Treated Set (TS) who provided at least one primary or secondary PK parameter that was not excluded due to important protocol violations relevant to the evaluation of PK or due to PK non-evaluability.
AUC0-tz, area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
Outcome measures
| Measure |
BI 1015550 24 mg fed (Test, T)
n=11 Participants
Subjects were treated orally with single dose of BI 1015550 4x6 milligrams (mg) (24 mg) tablets with 240 mL of water under fed condition on day 1.
|
BI 1015550 24 mg fast (Reference, R)
n=12 Participants
Subjects were treated orally with single dose of BI 1015550 4x6 mg (24 mg) tablets with 240 mL of water under fast condition on day 1.
|
|---|---|---|
|
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)
|
4164.32 nanomole*hours/Liter (nmol*h/L)
Standard Error NA
Adjusted geometric standard error = 1.06
|
4057.42 nanomole*hours/Liter (nmol*h/L)
Standard Error NA
Adjusted geometric standard error = 1.06
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.Population: PKS
Cmax, maximum measured concentration of BI 1015550 in plasma. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
Outcome measures
| Measure |
BI 1015550 24 mg fed (Test, T)
n=11 Participants
Subjects were treated orally with single dose of BI 1015550 4x6 milligrams (mg) (24 mg) tablets with 240 mL of water under fed condition on day 1.
|
BI 1015550 24 mg fast (Reference, R)
n=12 Participants
Subjects were treated orally with single dose of BI 1015550 4x6 mg (24 mg) tablets with 240 mL of water under fast condition on day 1.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
|
404.34 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.06
|
511.29 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.06
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 3:00 (hours:minutes) before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 120:00 (hours:minutes) after drug administration on day 1.Population: PKS
AUC0-inf, area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Adjusted mean estimates and their difference on log-scale were back-transformed to the original scale.
Outcome measures
| Measure |
BI 1015550 24 mg fed (Test, T)
n=11 Participants
Subjects were treated orally with single dose of BI 1015550 4x6 milligrams (mg) (24 mg) tablets with 240 mL of water under fed condition on day 1.
|
BI 1015550 24 mg fast (Reference, R)
n=12 Participants
Subjects were treated orally with single dose of BI 1015550 4x6 mg (24 mg) tablets with 240 mL of water under fast condition on day 1.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
4232.24 nmol*h/L
Standard Error NA
Adjusted geometric standard error = 1.06
|
4131.48 nmol*h/L
Standard Error NA
Adjusted geometric standard error = 1.06
|
Adverse Events
BI 1015550 24 mg fed (Test, T)
BI 1015550 24 mg fast (Reference, R)
Total on treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1015550 24 mg fed (Test, T)
n=11 participants at risk
Subjects were treated orally with single dose of BI 1015550 4x6 mg (24 mg) tablets with 240 mL of water under fed condition on day 1.
|
BI 1015550 24 mg fast (Reference, R)
n=12 participants at risk
Subjects were treated orally with single dose of BI 1015550 4x6 mg (24 mg) tablets with 240 mL of water under fasted condition on day 1.
|
Total on treatment
n=12 participants at risk
Subjects who were treated orally with single dose of BI 1015550 4x6 mg (24 mg) tablets with 240 mL of water under fed / fasted conditions on day 1.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
16.7%
2/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
25.0%
3/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/11 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
8.3%
1/12 • Adverse events: from drug administration in both periods, up to 168 hours. All-cause mortality: from drug administration until end of study, up to day 15.
Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of study drug. The arm "total on treatment" is composed of all the subjects, independently from the treatment received.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place