Trial Outcomes & Findings for A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body (NCT NCT06408870)
NCT ID: NCT06408870
Last Updated: 2025-12-01
Results Overview
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
COMPLETED
PHASE1
64 participants
Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.
2025-12-01
Participant Flow
The open-label, randomised, single-dose, two-way crossover study aimed to assess the bioequivalence of the BI 1015550 low dose Formulation C2 and the BI 1015550 low dose Formulation C1 (Phase 3 formulation) following oral administration in healthy subjects.
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 Formulation C1 (Reference, R) then BI 1015550 Formulation C2 (Test, T)
For this two period crossover study arm, participants received treatment in the following order:
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 1).
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 2).
In between the treatment periods, participants went through a washout period of 10 days.
|
BI 1015550 Formulation C2 (Test, T) then BI 1015550 Formulation C1 (Reference, R)
For this two period crossover study arm, participants received treatment in the following order:
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 1).
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 2).
In between the treatment periods, participants went through a washout period of 10 days.
|
|---|---|---|
|
Treatment period 1
STARTED
|
32
|
32
|
|
Treatment period 1
COMPLETED
|
32
|
32
|
|
Treatment period 1
NOT COMPLETED
|
0
|
0
|
|
Washout period
STARTED
|
32
|
32
|
|
Washout period
COMPLETED
|
29
|
32
|
|
Washout period
NOT COMPLETED
|
3
|
0
|
|
Treatment period 2
STARTED
|
29
|
32
|
|
Treatment period 2
COMPLETED
|
29
|
32
|
|
Treatment period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
BI 1015550 Formulation C1 (Reference, R) then BI 1015550 Formulation C2 (Test, T)
For this two period crossover study arm, participants received treatment in the following order:
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 1).
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 2).
In between the treatment periods, participants went through a washout period of 10 days.
|
BI 1015550 Formulation C2 (Test, T) then BI 1015550 Formulation C1 (Reference, R)
For this two period crossover study arm, participants received treatment in the following order:
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 1).
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 2).
In between the treatment periods, participants went through a washout period of 10 days.
|
|---|---|---|
|
Washout period
Withdrawal by Subject
|
1
|
0
|
|
Washout period
Adverse Event
|
2
|
0
|
Baseline Characteristics
A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body
Baseline characteristics by cohort
| Measure |
BI 1015550 Formulation C1 (Reference, R) Then BI 1015550 Formulation C2 (Test, T)
n=32 Participants
For this two period crossover study arm, participants received treatment in the following order:
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 1).
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 2).
In between the treatment periods, participants went through a washout period of 10 days.
|
BI 1015550 Formulation C2 (Test, T) Then BI 1015550 Formulation C1 (Reference, R)
n=32 Participants
For this two period crossover study arm, participants received treatment in the following order:
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h (period 1).
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h (period 2).
In between the treatment periods, participants went through a washout period of 10 days.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.7 Years
STANDARD_DEVIATION 8.1 • n=121 Participants
|
35.5 Years
STANDARD_DEVIATION 8.8 • n=122 Participants
|
34.6 Years
STANDARD_DEVIATION 8.5 • n=243 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=121 Participants
|
15 Participants
n=122 Participants
|
21 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=121 Participants
|
17 Participants
n=122 Participants
|
43 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=121 Participants
|
32 Participants
n=122 Participants
|
62 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=121 Participants
|
31 Participants
n=122 Participants
|
60 Participants
n=243 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.Population: Pharmacokinetic parameter analysis set (PKS): included all subjects in the treated set (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Participants in both arms are not mutually exclusive.
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Outcome measures
| Measure |
BI 1015550 Formulation C1 (Reference, R)
n=64 Participants
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h.
|
BI 1015550 Formulation C2 (Test, T)
n=61 Participants
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
1270.92 hours*nanomole/Liter (hrs*nmol/L)
Standard Error na
Adjusted geometric standard error = 1.04
|
1320.24 hours*nanomole/Liter (hrs*nmol/L)
Standard Error na
Adjusted geometric standard error = 1.04
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.Population: Pharmacokinetic parameter analysis set (PKS): included all subjects in the treated set (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Participants in both arms are not mutually exclusive.
Maximum measured concentration of nerandomilast in plasma (Cmax) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Outcome measures
| Measure |
BI 1015550 Formulation C1 (Reference, R)
n=64 Participants
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h.
|
BI 1015550 Formulation C2 (Test, T)
n=61 Participants
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h.
|
|---|---|---|
|
Maximum Measured Concentration of Nerandomilast in Plasma (Cmax)
|
218.84 nanomole/Liter (nmol/L)
Standard Error na
Adjusted geometric standard error = 1.04
|
230.48 nanomole/Liter (nmol/L)
Standard Error na
Adjusted geometric standard error = 1.04
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) prior to and at 15minutes (min), 30min, 45min, 1hrs, 1:15hrs, 1:30hrs, 1:45hrs, 2hrs, 2:30hrs, 3hrs, 3:30hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs, 34hrs, 48hrs, 58hrs, 72hrs, 96hrs, 120hrs, and 144hrs after nerandomilast intake.Population: Pharmacokinetic parameter analysis set (PKS): included all subjects in the treated set (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Participants in both arms are not mutually exclusive.
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented. The statistical model applied was an analysis of variance (ANOVA), with 'subjects within sequence' as a random effect and 'sequence,' 'period,' and 'treatment' as fixed effects.
Outcome measures
| Measure |
BI 1015550 Formulation C1 (Reference, R)
n=64 Participants
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h.
|
BI 1015550 Formulation C2 (Test, T)
n=61 Participants
Participants received a single oral dose of nerandomilast (BI 10105550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
1284.94 hours*nanomole/Liter (hrs*nmol/L)
Standard Error na
Adjusted geometric standard error = 1.04
|
1333.23 hours*nanomole/Liter (hrs*nmol/L)
Standard Error na
Adjusted geometric standard error = 1.04
|
Adverse Events
BI 1015550 Formulation C1 (Reference, R)
BI 1015550 Formulation C2 (Test, T)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1015550 Formulation C1 (Reference, R)
n=64 participants at risk
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C1, titanium dioxide \[TiO2\]-containing phase III formulation, reference (R)) with 240 mL water after an overnight fast of at least 10 h.
|
BI 1015550 Formulation C2 (Test, T)
n=61 participants at risk
Participants received a single oral dose of nerandomilast (BI 1015550), a low dose film coated tablet (formulation C2, titanium dioxide \[TiO2\] free, test (T)) with 240 mL water after an overnight fast of at least 10 h.
|
|---|---|---|
|
General disorders
Fatigue
|
6.2%
4/64 • For all adverse events (AEs): From first nerandomilast intake until end of residual effect period (REP), up to 7 days. For all-cause mortality: From first nerandomilast intake until end of follow-up, up to 28 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses. Participants in both arms are not mutually exclusive.
|
0.00%
0/61 • For all adverse events (AEs): From first nerandomilast intake until end of residual effect period (REP), up to 7 days. For all-cause mortality: From first nerandomilast intake until end of follow-up, up to 28 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses. Participants in both arms are not mutually exclusive.
|
|
Nervous system disorders
Headache
|
18.8%
12/64 • For all adverse events (AEs): From first nerandomilast intake until end of residual effect period (REP), up to 7 days. For all-cause mortality: From first nerandomilast intake until end of follow-up, up to 28 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses. Participants in both arms are not mutually exclusive.
|
16.4%
10/61 • For all adverse events (AEs): From first nerandomilast intake until end of residual effect period (REP), up to 7 days. For all-cause mortality: From first nerandomilast intake until end of follow-up, up to 28 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses. Participants in both arms are not mutually exclusive.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
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