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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509889-38-00 | Registry Identifier | CTIS | |
| U1111-1301-0891 | Other Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerandomilast fasted state (Reference (R))/Nerandomilast fed state Test (T) | Experimental | 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. |
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| Nerandomilast fed state (Test (T))/Nerandomilast fasted state (Reference (R)) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | Participants received a single 18 mg Nerandomilast Formulation C2 film-coated tablet either after an overnight fast of at least 10 hours or following a high-fat, high-calorie meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) (AUC0-tz) | 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. | 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. |
| Maximum Measured Concentration of Nerandomilast in Plasma (Cmax) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 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. |
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Inclusion Criteria :
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13627 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| period 1 |
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| Washout period |
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| Period 2 |
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Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) (AUC0-tz) | 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. | 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. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomol/Liter (h*nmol/L) | 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. |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nerandomilast fasted state (Reference (R)) | Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 018002430127 | 001 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2024 | Oct 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 6, 2024 | Oct 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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| 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. |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug. | Count of Participants | Participants |
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| Race (NIH/OMB) | Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug. | Count of Participants | Participants |
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| Primary | Maximum Measured Concentration of Nerandomilast in Plasma (Cmax) | 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. | 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. | Posted | Geometric Least Squares Mean | Standard Error | nanomol/Liter (nmol/L) | 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. |
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| Secondary | Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 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. | 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. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomol/Liter (h*nmol/L) | 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. |
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| 0 |
| 18 |
| 0 |
| 18 |
| 8 |
| 18 |
| EG001 | Nerandomilast fed state (Test (T)) | Participants received one 18 mg Nerandomilast Formulation C2 film-coated tablet following a high fat/high calorie meal. | 0 | 18 | 0 | 18 | 7 | 18 |
| Catheter site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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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.