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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511245-18-00 | Registry Identifier | CTIS registry | |
| U1111-1304-2287 | Registry Identifier | WHO register - International Clinical Trials Registry Platform (ICTRP) |
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The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmacokinetics of the new formulation following oral administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerandomilast (18 mg) in treatment sequence R-T1-T2 | Experimental | Participants first received a single oral dose of 1 tablet of 18 milligrams (mg) nerandomilast adult formulation in the fasted state (Reference treatment, R), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (Treatment, T1), and then 18 tablets of 1 mg of nerandomilast pediatric formulation in the fed state as a single oral dose (Treatment, T2). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (hrs) for R and T1, or after a high-fat, high-calorie breakfast for T2. |
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| Nerandomilast (18 mg) in treatment sequence T1-T2-R | Experimental | Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), and then a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2. |
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| Nerandomilast (18 mg) in treatment sequence T2-R-T1 | Experimental | Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), followed by a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R), and then a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerandomilast 18 mg - adult formulation | Drug | BI 1015550, oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T1 vs Reference R | AUC0-tz (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% confidence interval (CI). | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
| AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T2 vs T1 | AUC0-tz (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Treatment T1 vs Reference R | AUC0-∞ (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | 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: https://www.mystudywindow.com/msw/datatransparency
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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 trial was an open-label, single dose, 3-way crossover design. Subjects were randomly allocated to one 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nerandomilast (18 mg) in Treatment Sequence R-T1-T2 | Participants first received a single oral dose of 1 tablet of 18 milligrams (mg) nerandomilast adult formulation in the fasted state (Reference treatment, R), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (Treatment, T1), and then 18 tablets of 1 mg of nerandomilast pediatric formulation in the fed state as a single oral dose (Treatment, T2). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (hrs) for R and T1, or after a high-fat, high-calorie breakfast for T2. |
| FG001 | Nerandomilast (18 mg) in Treatment Sequence T1-T2-R | Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), and then a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2. |
| FG002 | Nerandomilast (18 mg) in Treatment Sequence T2-R-T1 | Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), followed by a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R), and then a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Washout Period 1 (7 days) |
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| Treatment Period 2 |
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| Washout Period 2 (7 days) |
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| Treatment Period 3 |
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Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug. The number of subjects reported in each arm represents the number of subjects who took the first treatment in the respective sequence.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nerandomilast (18 mg) in Treatment Sequence R-T1-T2 | Participants first received a single oral dose of 1 tablet of 18 milligrams (mg) nerandomilast adult formulation in the fasted state (Reference treatment, R), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (Treatment, T1), and then 18 tablets of 1 mg of nerandomilast pediatric formulation in the fed state as a single oral dose (Treatment, T2). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (hrs) for R and T1, or after a high-fat, high-calorie breakfast for T2. |
| Units | Counts |
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| 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 | Mean |
| 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 | AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T1 vs Reference R | AUC0-tz (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% confidence interval (CI). | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. 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. Only participants with available data were analyzed. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomoles/Liter (h·nmol/L) |
Adverse events: From intake of trial medication till end of the residual effect period (REP), up to 7 days for each treatment. All-Cause Mortality: Up to 7 days (REP) for each treatment (R, T1, T2), then follow-up (13 days), up to a total of 34 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.
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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 18 mg Adult Fasted State (Reference R) | Participants received a single oral dose of 1 tablet of 18 mg nerandomilast adult formulation in the fasted state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 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 | Apr 11, 2025 | Nov 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2025 | Nov 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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| Nerandomilast 1 mg - paediatric formulation | Drug | BI 1015550, oral tablet |
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| Cmax (Maximum Measured Concentration of Nerandomilast in Plasma) for Treatment T1 vs Reference R |
Cmax (maximum measured concentration of nerandomilast in plasma) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. |
| Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
| Cmax (Maximum Measured Concentration of Nerandomilast in Plasma) for Treatment T2 vs T1 | Cmax (maximum measured concentration of nerandomilast in plasma) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
| Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
| AUC0-∞ (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Treatment T2 vs T1 | AUC0-∞ (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
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| BG001 | Nerandomilast (18 mg) in Treatment Sequence T1-T2-R | Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1), followed by a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), and then a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2. |
| BG002 | Nerandomilast (18 mg) in Treatment Sequence T2-R-T1 | Participants first received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state (T2), followed by a single oral dose of 18 mg of nerandomilast adult formulation in the fasted state (R), and then a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state (T1). Treatments were separated by a wash-out period of at least 7 days and treatments were taken with 240 mL of water after an overnight fast of at least 10 hrs for R and T1, or after a high-fat, high-calorie breakfast for T2. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
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| Primary | AUC0-tz (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Treatment T2 vs T1 | AUC0-tz (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. 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. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomoles/Liter (h·nmol/L) | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
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| Primary | Cmax (Maximum Measured Concentration of Nerandomilast in Plasma) for Treatment T1 vs Reference R | Cmax (maximum measured concentration of nerandomilast in plasma) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. 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. Only participants with available data were analyzed. | Posted | Geometric Least Squares Mean | Standard Error | nanomoles/Liter (nmol/L) | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
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| Primary | Cmax (Maximum Measured Concentration of Nerandomilast in Plasma) for Treatment T2 vs T1 | Cmax (maximum measured concentration of nerandomilast in plasma) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. 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. | Posted | Geometric Least Squares Mean | Standard Error | nanomoles/Liter (nmol/L) | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
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| Secondary | AUC0-∞ (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Treatment T1 vs Reference R | AUC0-∞ (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity) for Treatment T1 vs Reference R is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. 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. Only participants with available data were analyzed. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomoles/Liter (h·nmol/L) | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
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| Secondary | AUC0-∞ (Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Treatment T2 vs T1 | AUC0-∞ (area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity) for Treatment T2 vs T1 is reported. Geometric least square mean (adjusted geometric mean) and standard error (adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale restricted to the data of interest for each comparison. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the effect 'subjects within sequences' as random and the other effects of sequence, period and treatment were considered as fixed. These quantities were then back-transformed to the original scale to provide the point estimate and the 90% CI. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided 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. 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. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomoles/Liter (h·nmol/L) | Within 3 hours (hrs) before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 58, 72, and 96 hrs after drug administration. For dosing after 58hrs, a tolerance of +/- 2 hrs was allowed. |
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| 0 |
| 14 |
| 0 |
| 14 |
| 6 |
| 14 |
| EG001 | Nerandomilast 18 mg Ped Fasted State (Treatment T1) | Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fasted state. | 0 | 15 | 0 | 15 | 11 | 15 |
| EG002 | Nerandomilast 18 mg Ped Fed State (Treatment T2) | Participants received a single oral dose of 18 tablets of 1 mg nerandomilast pediatric formulation in the fed state. | 0 | 15 | 0 | 15 | 7 | 15 |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
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