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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001052-34 | EudraCT Number |
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The main objective of this trial is to investigate the relative bioavailability of 100 mg nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg nintedanib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nintedanib 4 X 25 mg (T) then nintedanib 1 X 100 mg (R)) | Experimental | first test (T), then reference (R) treatment |
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| nintedanib 1 X 100 mg (R) then nintedanib 4 X 25 mg (T) | Experimental | first reference (R), then test (T) treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nintedanib 25 mg | Drug | soft gelatin capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration. |
| Maximum Measured Concentration of Nintedanib in Plasma (Cmax) | Maximum measured concentration of nintedanib in plasma (Cmax) is reported. | For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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-∞) is reported. | For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration. |
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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, except for the following exclusions:
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 was a phase I trial to test the relative bioavailability of 100 milligram (mg) nintedanib (Ofev®) given as four capsules of 25 mg compared to one capsule of 100 mg following oral administration in healthy male subjects (an open-label, randomised, single-dose, two-period, two-sequence crossover study).
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| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib 1 X 100 mg (R) / Nintedanib 4 X 25 mg (T) | On Day 1 of Period 1 participants were administered once 1 soft gelatin capsule of 100 milligram (mg) of nintedanib (reference treatment (R)) orally with 240 milliliter (mL) of water after breakfast. On Day 1 of Period 2 participants were administered one single intake of 4 soft gelatin capsules of 25 mg of nintedanib (total administered dose = 100 mg) (test treatment (T)) orally with 240 mL of water after breakfast. There was a washout period of at least 7 days between the treatments. |
| FG001 | Nintedanib 4 X 25 mg (T) / Nintedanib 1 X 100 mg (R) | On Day 1 of Period 1 participants were administered one single intake of 4 soft gelatin capsules of 25 milligram (mg) of nintedanib (total administered dose = 100 mg) (test treatment (T)) orally with 240 milliliter (mL) of water after breakfast. On Day 1 of Period 2 participants were administered once 1 soft gelatin capsule of 100 mg of nintedanib (reference treatment (R)) orally with 240 mL of water after breakfast. There was a washout period of at least 7 days between the treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period 1 |
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| Period 2 |
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Treated set (TS): TS included all subjects who were randomised and treated with at least 1 dose of the investigational medicinal product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib 1 X 100 mg (R) / Nintedanib 4 X 25 mg (T) | On Day 1 of Period 1 participants were administered once 1 soft gelatin capsule of 100 milligram (mg) of nintedanib (reference treatment (R)) orally with 240 milliliter (mL) of water after breakfast. On Day 1 of Period 2 participants were administered one single intake of 4 soft gelatin capsules of 25 mg of nintedanib (total administered dose = 100 mg) (test treatment (T)) orally with 240 mL of water after breakfast. There was a washout period of at least 7 days between the treatments. |
| 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 the Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least 1 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 contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hours (h) *nanogram(ng)/milliliter (mL) | For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration. |
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For both arms: From drug administration until 14 days thereafter.
Treated set (TS): TS included all subjects who were randomised and treated with at least 1 dose of the investigational medicinal product.
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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 | Nintedanib 1 X 100 mg (R) | This arm includes all participants who were administered once 1 soft gelatin capsule of of 100 milligram (mg) of nintedanib (reference treatment (R)) orally with 240 milliliter (mL) of water after breakfast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | 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 | Jun 2, 2021 | Jul 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2021 | Jul 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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| nintedanib 100 mg | Drug | soft gelatin capsule |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Nintedanib 4 X 25 mg (T) / Nintedanib 1 X 100 mg (R) | On Day 1 of Period 1 participants were administered one single intake of 4 soft gelatin capsules of 25 milligram (mg) of nintedanib (total administered dose = 100 mg) (test treatment (T)) orally with 240 milliliter (mL) of water after breakfast. On Day 1 of Period 2 participants were administered once 1 soft gelatin capsule of 100 mg of nintedanib (reference treatment (R)) orally with 240 mL of water after breakfast. There was a washout period of at least 7 days between the treatments. |
| BG002 | 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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| Nintedanib 1 X 100 mg (R) |
This arm includes all participants who were administered once 1 soft gelatin capsule of 100 milligram (mg) of nintedanib (reference treatment (R)) orally with 240 milliliter (mL) of water after breakfast. |
| OG001 | Nintedanib 4 X 25 mg (T) | This arm includes all participants who were administered one single intake of 4 soft gelatin capsules of 25 mg of nintedanib (total administered dose = 100 mg) (test treatment (T)) orally with 240 milliliter (mL) of water after breakfast. |
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| Primary | Maximum Measured Concentration of Nintedanib in Plasma (Cmax) | Maximum measured concentration of nintedanib in plasma (Cmax) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least 1 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 contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Deviation | nanogram (ng)/milliliter (mL) | For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration. |
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| Secondary | 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-∞) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least 1 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 contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hours * nanogram/milliliter | For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration. |
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| 0 |
| 19 |
| 0 |
| 19 |
| 10 |
| 19 |
| EG001 | Nintedanib 4 X 25 mg (T) | This arm includes all participants who were administered one single intake of 4 soft gelatin capsules of 25 mg of nintedanib (total administered dose = 100 mg) (test treatment (T)) orally with 240 milliliter (mL) of water after breakfast. | 0 | 19 | 0 | 19 | 5 | 19 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Macule | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Other |
| Other |