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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004880-28 | EudraCT Number |
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To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI 1358894.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1358894 - test - fasted | Experimental | A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours. |
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| BI 1358894 - test - fed | Experimental | A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal. |
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| BI 1358894 - reference - fasted | Experimental | A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours. |
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| BI 1358894 - reference - fed | Experimental | A single dose of 00 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1358894, intended Commercial Formulation (iCF) (T) | Drug | A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). | Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period. |
| Maximum Measured Concentration of BI 1358894 in Plasma (Cmax) | Maximum measured concentration of BI 1358894 in plasma (Cmax). | Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period. |
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Inclusion Criteria:
Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Either male subject, or female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before administration of trial medication until 30 days after trial completion:
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/datasharing
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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 randomised, open-label, single-dose, four-period and four-sequence crossover trial in healthy male and female subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Fasted - Reference Fasted - Test Fed - Reference Fed | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fasted - Reference fasted - Test fed - Reference fed, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| FG001 | Reference Fasted - Test Fasted - Reference Fed - Test Fed | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fasted - Test fasted - Reference fed - Test fed, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| FG002 | Test Fed - Reference Fed - Reference Fasted - Test Fasted | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fed - Reference fed - Reference fasted - Test fasted, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| FG003 | Reference Fed - Test Fed - Test Fasted - Reference Fasted | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fed - Test fed - Test fasted - Reference fasted, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Wash-out Period 1 to 2 |
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| Period 2 |
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| Wash-out Period 2 to 3 |
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| Wash-out Period 3 to 4 |
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| Period 4 |
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Treated set: All subjects who were treated with at least one dose of the trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Fasted - Reference Fasted - Test Fed - Reference Fed | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fasted - Reference fasted - Test fed - Reference fed, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| 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 BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). | All subjects who were treated with at least one dose of the trial drug and who provided at least one pharmacokinetic (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 were included in the pharmacokinetic analysis set (PKS). Only subjects with non-missing results were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanomole/Liter | Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period. |
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All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects 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 | BI 1358894 - Reference - Fasted | A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 25.0 | 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 | Apr 20, 2022 | Feb 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2022 | Feb 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000730434 | TRPC inhibitor BI 1358894 |
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| BI 1358894, Trial Formulation 2 (TFII) (R) | Drug | A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Reference Fasted - Test Fasted - Reference Fed - Test Fed | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fasted - Test fasted - Reference fed - Test fed, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| BG002 | Test Fed - Reference Fed - Reference Fasted - Test Fasted | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fed - Reference fed - Reference fasted - Test fasted, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| BG003 | Reference Fed - Test Fed - Test Fasted - Reference Fasted | Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fed - Test fed - Test fasted - Reference fasted, treatments were separated by a wash-out phase of at least 17 days. Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning. Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning. Fed: treatment given following a high-fat, high-calorie meal. Fasted: treatment following an overnight fast of at least 10 hours. |
| BG004 | 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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A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours. |
| OG001 | BI 1358894 - Test - Fed | A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal. |
| OG002 | BI 1358894 - Reference - Fasted | A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours. |
| OG003 | BI 1358894 - Reference - Fed | A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal. |
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| Primary | Maximum Measured Concentration of BI 1358894 in Plasma (Cmax) | Maximum measured concentration of BI 1358894 in plasma (Cmax). | All subjects who were treated with at least one dose of the trial drug and who provided at least one pharmacokinetic (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 were included in the pharmacokinetic analysis set (PKS). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter | Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period. |
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| Secondary | Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | All subjects who were treated with at least one dose of the trial drug and who provided at least one pharmacokinetic (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 were included in the pharmacokinetic analysis set (PKS). Only subjects with non-missing results were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanomole/Liter | Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period. |
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| 0 |
| 21 |
| 0 |
| 21 |
| 15 |
| 21 |
| EG001 | BI 1358894 - Reference - Fed | A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal. | 0 | 21 | 0 | 21 | 13 | 21 |
| EG002 | BI 1358894 - Test - Fasted | A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours. | 0 | 21 | 0 | 21 | 13 | 21 |
| EG003 | BI 1358894 - Test - Fed | A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal. | 0 | 21 | 0 | 21 | 13 | 21 |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Geometric mean ratio [%] | 99.7 | 2-Sided | 90 | 88.7 | 112.0 | Ratio is calculated as test/reference. Geometric Standard Error = 1.070. | Other |
| Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Geometric mean ratio [%] | 153.6 | 2-Sided | 90 | 126.0 | 187.3 | Ratio is calculated as fed/fasted. Geometric Standard Error = 1.121. | Other |
| Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Geometric mean ratio [%] | 121.4 | 2-Sided | 90 | 99.6 | 147.8 | Ratio is calculated as fed/fasted. Geometric Standard Error = 1.120. | Other |
| Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Geometric mean ratio [%] | 100.4 | 2-Sided | 90 | 96.8 | 104.1 | Ratio is calculated as test/reference. Geometric Standard Error = 1.021. | Other |
| Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Geometric mean ratio [%] | 202.6 | 2-Sided | 90 | 179.6 | 228.5 | Ratio is calculated as fed/fasted. Geometric Standard Error = 1.072. | Other |
| Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. | Geometric mean ratio [%] | 172.3 | 2-Sided | 90 | 158.2 | 187.7 | Ratio is calculated as fed/fasted. Geometric Standard Error = 1.050. | Other |