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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505522-34-00 | Registry Identifier | CTIS | |
| U1111-1292-0376 | Registry Identifier | WHO registry |
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The main objective of this trial is to investigate the induction effect of multiple oral doses of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference treatment/Test treatment | Experimental | In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2. In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast were administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2. A washout period of at least 72 hours separated the last drug administration in the reference period from the first drug administration in the test period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | BI 1015550 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2) |
| Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2) |
| Maximum Measured Concentration of Pirfenidone in Plasma (Cmax) | Maximum measured concentration of pirfenidone in plasma (Cmax). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2) |
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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:
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14 participants who met the inclusion and none of the exclusion criteria were included in the study. All 14 participants were treated in period 1. One of the 14 participants was discontinued after period 1 due to an adverse event. 13 participants were treated in period 2 and 1 of these subjects discontinue participation due to on-treatment adverse events. All 14 subjects completed the planned trial assessments. Participants were free to withdraw from the clinical trial at any time.
This is an open-label, two-period, fixed-sequence crossover trial to investigate the effect of multiple oral doses of 18 mg nerandomilast on the pharmacokinetics of single oral doses of 100 mg nintedanib or 267 mg pirfenidone.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference treatment/Test treatment | In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2. In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast were administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2. A washout period of at least 72 hours separated the last drug administration in the reference period from the first drug administration in the test period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Reference treatment period) |
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| Washout period |
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| Period 2 (Test treatment period) |
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Treated set (TS): The treated set included all subjects who were treated with at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference Treatment/Test Treatment | In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2. In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast were administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2. A washout period of at least 72 hours separated the last drug administration in the reference period from the first drug administration in the test period. |
| 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 | Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hour * nanogram / milliliter (h*ng/mL) | At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2) |
Treated set (TS): The treated set included all subjects who were treated with at least 1 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 | Pirfenidone | A single dose of 267 mg film-coated tablet of pirfenidone was administered orally on Day 1 in the reference (R) treatment period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim, Call Centre | 18002430127 | 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 | Oct 5, 2023 | Oct 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2024 | Oct 29, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
| C530716 | nintedanib |
| C093844 | pirfenidone |
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Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
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| Nintedanib | Drug | Soft capsules |
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| Pirfenidone | Drug | Film-coated tablets |
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| Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2) |
| Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2) |
| Maximum Measured Concentration of Nintedanib in Plasma (Cmax) | Maximum measured concentration of nintedanib in plasma (Cmax). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2) |
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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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| Primary | Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hour * nanogram / milliliter (h*ng/mL) | At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2) |
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| Primary | Maximum Measured Concentration of Pirfenidone in Plasma (Cmax) | Maximum measured concentration of pirfenidone in plasma (Cmax). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | nanogram / milliliter (ng/mL) | At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2) |
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| Primary | Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hour * nanogram / milliliter (h*ng/mL) | At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2) |
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| Primary | Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hour * nanogram / milliliter (h*ng/mL) | At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2) |
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| Primary | Maximum Measured Concentration of Nintedanib in Plasma (Cmax) | Maximum measured concentration of nintedanib in plasma (Cmax). Geometric least squares mean (adjusted geometric mean) and the standard error (actually 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. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided data for at least 1 primary PK endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was to be included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available data were included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | nanogram / milliliter (ng/mL) | At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2) |
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| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Nintedanib | A single dose of 100 mg soft capsule of nintedanib was administered orally on Day 2 in the reference (R) treatment period 1. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG002 | Nerandomilast | One film-coated tablet of 18 mg nerandomilast (BI 1015550) was administered orally twice daily for 8 days (Day -6 to Day -1 and Day 3 to Day 4) in the test (T) treatment period 2. | 0 | 13 | 0 | 13 | 3 | 13 |
| EG003 | Nerandomilast+pirfenidone | One film-coated tablet of 18 mg nerandomilast (BI 1015550) was administered orally twice daily together with a single dose of 267 mg pirfenidone on Day 1 in the test (T) treatment period 2. | 0 | 13 | 0 | 13 | 1 | 13 |
| EG004 | Nerandomilast+nintedanib | One film-coated tablet of 18 mg nerandomilast (BI 1015550) was administered orally twice daily together with a single dose of 100 mg nintedanib on Day 2 in the test (T) treatment period 2. | 0 | 13 | 0 | 13 | 7 | 13 |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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