Trial Outcomes & Findings for A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food (NCT NCT06415045)

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 is presented. Geometric least square mean (adjusted geometric mean) and 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. These quantities will then be back-transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. This model will include effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Within 3 hours before Nerandomilast administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 3:30, 4:00, 6:00, 8:00, 11:00, 12:00, 24:00, 34:00, 48:00, 58:00, 72:00, 96:00, 120:00, and 144:00 hours after administration.

Results posted on

2025-12-01

Participant Flow

This open-label, single-dose, 2-period, 2-sequence crossover trial investigated how food affects the pharmacokinetics of an 18 mg nerandomilast tablet (Formulation C2). Subjects received nerandomilast in a fasting (Reference (R)) and fed (Test (T)) state with a minimum 10-day washout period in between and were randomized to the sequences R-T or T-R.

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

Participant milestones
Measure	Nerandomilast fasted state (Reference (R))/Nerandomilast fed state Test (T) Nerandomilast fasted state Reference (R)/Nerandomilast fed state Test (T) Two period crossover separated by a wash-out of at least 10 days: Period 1: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours. Period 2: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.	Nerandomilast fed state (Test (T))/Nerandomilast fasted state (Reference (R)) Nerandomilast fed state Test (T)/Nerandomilast fasted state Reference (R) Two period crossover separated by a wash-out of at least 10 days: Period 1: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal. Period 2: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.
period 1 STARTED	9	9
period 1 COMPLETED	9	9
period 1 NOT COMPLETED	0	0
Washout period STARTED	9	9
Washout period COMPLETED	9	9
Washout period NOT COMPLETED	0	0
Period 2 STARTED	9	9
Period 2 COMPLETED	9	9
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nerandomilast Fasted State (Reference (R))/Nerandomilast Fed State Test (T) n=9 Participants Nerandomilast fasted state Reference (R)/Nerandomilast fed state Test (T) Two period crossover separated by a wash-out of at least 10 days: Period 1: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours. Period 2: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.	Nerandomilast Fed State (Test (T))/Nerandomilast Fasted State (Reference (R)) n=9 Participants Nerandomilast fed state Test (T)/Nerandomilast fasted state Reference (R) Two period crossover separated by a wash-out of at least 10 days: Period 1: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal. Period 2: Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.	Total n=18 Participants Total of all reporting groups
Age, Continuous	41.0 Years STANDARD_DEVIATION 7.1 • n=121 Participants	38.0 Years STANDARD_DEVIATION 6.5 • n=122 Participants	39.5 Years STANDARD_DEVIATION 6.8 • n=243 Participants
Sex: Female, Male Female	4 Participants n=121 Participants	4 Participants n=122 Participants	8 Participants n=243 Participants
Sex: Female, Male Male	5 Participants n=121 Participants	5 Participants n=122 Participants	10 Participants n=243 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=121 Participants	1 Participants n=122 Participants	1 Participants n=243 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=121 Participants	8 Participants n=122 Participants	17 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	0 Participants n=121 Participants	0 Participants n=122 Participants	0 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	9 Participants n=121 Participants	9 Participants n=122 Participants	18 Participants n=243 Participants
Race (NIH/OMB) More than one race	0 Participants n=121 Participants	0 Participants n=122 Participants	0 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 before Nerandomilast administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 3:30, 4:00, 6:00, 8:00, 11:00, 12:00, 24:00, 34:00, 48:00, 58:00, 72:00, 96:00, 120:00, and 144:00 hours after administration.

Population: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one 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.

Outcome measures

Outcome measures
Measure	Nerandomilast fasted state (Reference (R)) n=18 Participants Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.	Nerandomilast fed state (Test (T)) n=18 Participants Participants received One 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.
Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) (AUC0-tz)	2225.20 hournanomol/Liter (hnmol/L) Standard Error NA Geometric standard error = 1.07	2563.65 hournanomol/Liter (hnmol/L) Standard Error NA Geometric standard error = 1.07

PRIMARY outcome

Maximum measured concentration of Nerandomilast in plasma (Cmax) is presented. Geometric least square mean (adjusted geometric mean) and 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. These quantities will then be back-transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. This model will include effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.

Outcome measures

Outcome measures
Measure	Nerandomilast fasted state (Reference (R)) n=18 Participants Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.	Nerandomilast fed state (Test (T)) n=18 Participants Participants received One 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.
Maximum Measured Concentration of Nerandomilast in Plasma (Cmax)	412.88 nanomol/Liter (nmol/L) Standard Error NA Geometric standard error = 1.10	354.35 nanomol/Liter (nmol/L) Standard Error NA Geometric standard error = 1.10

SECONDARY outcome

Area under the concentration-time curve of Nerandomilast in plasma over the time interval from 0 extrapolated to infinity is presented. Geometric least square mean (adjusted geometric mean) and 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. These quantities will then be back-transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. This model will include effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.

Outcome measures

Outcome measures
Measure	Nerandomilast fasted state (Reference (R)) n=18 Participants Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.	Nerandomilast fed state (Test (T)) n=18 Participants Participants received One 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.
Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	2240.58 hournanomol/Liter (hnmol/L) Standard Error NA Geometric standard error = 1.07	2578.16 hournanomol/Liter (hnmol/L) Standard Error NA Geometric standard error = 1.07

Adverse Events

Nerandomilast fasted state (Reference (R))

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Nerandomilast fed state (Test (T))

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nerandomilast fasted state (Reference (R)) n=18 participants at risk Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours.	Nerandomilast fed state (Test (T)) n=18 participants at risk Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
Gastrointestinal disorders Flatulence	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	0.00% 0/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
General disorders Catheter site pain	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	0.00% 0/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
Infections and infestations Nasopharyngitis	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
Nervous system disorders Dizziness	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	0.00% 0/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
Nervous system disorders Headache	22.2% 4/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	27.8% 5/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
Reproductive system and breast disorders Dysmenorrhoea	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	0.00% 0/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 1/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.	0.00% 0/18 • Adverse event collection period: up to 7 days from first Nerandomilast administration. All-cause mortality: up to 28 days from first Nerandomilast administration. Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 018002430127

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.
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