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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000351-13 | EudraCT Number |
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The main objective of Part 1 of this trial is to investigate the absolute bioavailability of BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894 and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.
The main objective of Part 2 of this trial is to investigate the relative bioavailability of BI 1358894 administered as an oral suspension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1358894: Part 1: tablet (T1) - (C14) i.v (R1), Part 2: fasted (R2) - fed (T2) | Experimental | BI 1358894 |
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| BI 1358894: Part 1: tablet (T1) - (C14) i.v (R1), Part 2: fed (T2) - fasted (R2) | Experimental | BI 1358894 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1358894 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration (AUC0-infinity) | Area under the concentration-time curve of BI 1358894 over the time interval from 0 to infinity after i.v. administration and after oral administration (AUC0-infinity) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. Standard error is actually geometric standard error. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. | Within 2 hours (h) before and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description. |
| Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 312 h (AUC 0-312) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 312 h (AUC 0-312) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error. | Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Measured Concentration of BI 1358894 in Plasma After i.v. Administration and After Oral Administration (Cmax) | Maximum measured concentration of BI 1358894 in plasma after i.v. administration and after oral administration(Cmax) is reported. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | 9728 NZ | Netherlands |
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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 phase I trial which investigated the pharmacokinetics and absolute bioavailability of BI 1358894 administered orally as tablet co-administered with an intravenous microtracer dose of labelled [C-14]-BI 1358894 in healthy male volunteers via a non-randomised, open-label, fixed-sequence trial (part 1) followed by a randomised, openlabel, single-dose, two-period, two-sequence cross-over relative bioavailability trial in BI 1358894 oral suspension (part 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2) | In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg [C-14] labelled BI 1358894 (Reference 1-R1). After 15 days of washout the Part 2: Period 2 of the study started and participants received on Day 1 of Period 2 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2). After 17 days of washout Part 2: Period 3 started and participants received on Day 1 of Period 3 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Period 1+Washout |
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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 26, 2020 | Feb 4, 2025 |
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Part 1: non-randomized, fixed-sequence design Part 2: randomized, two-period, two-sequence, crossover design
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| BI 1358894 (C-14) intravenous solution | Drug | BI 1358894 mixed with [carbon labelled (C-14)] BI 1358894 |
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| BI 1358894 | Drug | Oral suspension |
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| Within 2 hours before and at 15 minutes (min), 30 min, 1 hour (h), 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description. |
| Part 2: Maximum Measured Concentration of BI 1358894 in Plasma After Administration of the Oral Suspension (Cmax) | Maximum measured concentration of BI 1358894 in plasma after administration of the oral suspension (Cmax) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error. | Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894. |
| Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After Administration of the Oral Suspension (AUC0-infinity) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity after administration of the oral suspension (AUC0-infinity) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error. | Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894. |
| FG001 | BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2) | In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg [C-14] labelled BI 1358894 (Reference 1-R1). After 15 days of washout Part 2: Period 2 started and participants received on Day 1 of Period 2 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). After 17 days of washout the Part 2: Period 3 of the study started and participants received on Day 1 of Period 3 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2). |
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| NOT COMPLETED |
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| Part 2: Period 2+Washout |
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| Part 2: Period 3+Washout |
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Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2) | In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg [C-14] labelled BI 1358894 (Reference 1-R1). After 15 days of washout the Part 2: Period 2 of the study started and participants received on Day 1 of Period 2 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2). After 17 days of washout Part 2: Period 3 started and participants received on Day 1 of Period 3 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). |
| BG001 | BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2) | In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg [C-14] labelled BI 1358894 (Reference 1-R1). After 15 days of washout Part 2: Period 2 started and participants received on Day 1 of Period 2 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). After 17 days of washout the Part 2: Period 3 of the study started and participants received on Day 1 of Period 3 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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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| 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 | Part 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration (AUC0-infinity) | Area under the concentration-time curve of BI 1358894 over the time interval from 0 to infinity after i.v. administration and after oral administration (AUC0-infinity) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. Standard error is actually geometric standard error. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. | Pharmacokinetic parameter analysis set (PKS): This set 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. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Least Squares Mean | Standard Error | hour*millimol/Liter/kilogram | Within 2 hours (h) before and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description. |
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| Primary | Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 312 h (AUC 0-312) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 312 h (AUC 0-312) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error. | Pharmacokinetic parameter analysis set (PKS): This set 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. For both arms 11 subjects were treated. | Posted | Geometric Least Squares Mean | Standard Error | hour* nanomol/Liter (h*nmol/L) | Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894. |
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| Secondary | Part 1: Maximum Measured Concentration of BI 1358894 in Plasma After i.v. Administration and After Oral Administration (Cmax) | Maximum measured concentration of BI 1358894 in plasma after i.v. administration and after oral administration(Cmax) is reported. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. | Pharmacokinetic parameter analysis set (PKS): This set 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. Descriptive and model-based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol/Liter (nmol/L) | Within 2 hours before and at 15 minutes (min), 30 min, 1 hour (h), 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description. |
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| Secondary | Part 2: Maximum Measured Concentration of BI 1358894 in Plasma After Administration of the Oral Suspension (Cmax) | Maximum measured concentration of BI 1358894 in plasma after administration of the oral suspension (Cmax) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error. | Pharmacokinetic parameter analysis set (PKS): This set 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. For both arms 11 subjects were treated. | Posted | Geometric Least Squares Mean | Standard Error | nanomol/Liter (nmol/L) | Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894. |
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| Secondary | Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After Administration of the Oral Suspension (AUC0-infinity) | Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity after administration of the oral suspension (AUC0-infinity) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error. | Pharmacokinetic parameter analysis set (PKS): This set 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. For both arms 11 subjects were treated. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomol/Liter (h*nmol/L) | Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894. |
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BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
Not provided
| 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 100 mg Tablet Fasted | Participants received on Day 1 of Part 1: Period 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). | 0 | 12 | 0 | 12 | 6 | 12 |
| EG001 | BI 1358894 (C-14) 100 ug i.v | Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg [C-14] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG002 | BI 1358894 100 mg Oral Suspension Fasted | Participants received one single dose of 100 milligram (mg) BI 1358894 administered as an oral suspension with 240 milliliter (mL) of water after an overnight fast of at least 10 hours when fasted (Reference 2-R2). | 0 | 11 | 0 | 11 | 6 | 11 |
| EG003 | BI 1358894 100 mg Oral Suspension Fed | Participants received one single dose of 100 milligram (mg) of BI 1358894 administered as an oral suspension with 240 milliliter (mL) of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). | 0 | 11 | 0 | 11 | 8 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Stress | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2021 | Feb 4, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000730434 | TRPC inhibitor BI 1358894 |
| C000615234 | Carbon-14 |
Not provided
Not provided
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | BI 1358894 100 mg Oral Suspension Fed | Participants received one single dose of 100 milligram (mg) of BI 1358894 administered as an oral suspension with 240 milliliter (mL) of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). |
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| BI 1358894 (C-14) 100 ug i.v |
Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg [C-14] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1. |
|
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| BI 1358894 100 mg Oral Suspension Fed |
Participants received one single dose of 100 milligram (mg) of BI 1358894 administered as an oral suspension with 240 milliliter (mL) of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). |
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| OG001 | BI 1358894 100 mg Oral Suspension Fed | Participants received one single dose of 100 milligram (mg) of BI 1358894 administered as an oral suspension with 240 milliliter (mL) of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). |
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