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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002003-10 | EudraCT Number |
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Part 1 (SRD (Single-rising dose)):
The primary objective of this trial part is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single dosing.
Part 2 (MRD (Multiple-rising dose)):
In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of multiple rising doses.
Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Single Dose (SD) | Placebo Comparator | Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
|
| Placebo Multiple Dose (MD) | Placebo Comparator | Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
|
| BI 1015550 36 milligram (mg) Single Dose (SD) | Experimental | Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
|
| BI 1015550 48 milligram (mg) Single Dose (SD) | Experimental | Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
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| BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Single Dose (SD) | Drug | Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events (AEs) | Number of subjects with drug-related Adverse Events (AEs). | For SRD: From the administration of study medication until 7 days, up to day 8. For MRD: From the first administration of study medication until 7 days after the last administration of study medication, i.e. up to 21 days after first drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 (SRD): Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Part 1 (SRD): Area under the concentration-time curve of the BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
In addition, the following trial-specific exclusion criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist site which ensured that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria was violated.
Safety, tolerability, and pharmacokinetics of BI 1015550 in healthy male subjects.
Single rising dose (SRD) part: Partially randomized within dose groups, placebo-controlled, single-blind, parallel-group design; Multiple rising dose (MRD) part: Partially randomized within dose groups, placebo-controlled, double-blind, parallel-group design.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Single Dose (SD) | Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
| FG001 | Placebo Multiple Dose (MD) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 28, 2017 | Oct 17, 2025 |
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Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
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| BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) | Experimental | Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
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| BI 1015550 Single Dose (SD) | Drug | Subjects received single dose of BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours |
|
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| Placebo Multiple Dose (MD) | Drug | Subjects received placebo tablet matching to BI 1015550 twice daily (bid) orally with 240 milligram (mL) of water after a moderate fat meal. |
|
| BI 1015550 Multiple Dose (MD) | Drug | Subjects received BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. |
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| Part 1 (SRD): Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | Part 1 (SRD): Maximum measured concentration of the BI 1015550 in plasma (Cmax). | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration |
| Part 2 (MRD) - After the First Dose : Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCτ,1) | Part 2 (MRD) - After the first dose : Area under the concentration-time curve of the BI 1015550 in plasma over a uniform dosing interval tau after administration of the first dose (AUCτ,1). | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration |
| Part 2 (MRD) - After the First Dose : Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | Part 2 (MRD) - After the first dose : Maximum measured concentration of the BI 1015550 in plasma (Cmax). | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration |
| Part 2 (MRD) - After the Last Dose: Area Under the Concentration-time Curve of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss) | Part 2 (MRD) - After the last dose: Area under the concentration-time curve of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss). | Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 311:55, 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00 |
| Part 2 (MRD) - After the Last Dose: Maximum Measured Concentration of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax,ss) | Part 2 (MRD) - After the last dose: Maximum measured concentration of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (Cmax,ss). | Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00 |
| Part 2 (MRD) - Accumulation Ratio Based on Cmax,ss (RA,Cmax) | Part 2 (MRD) - Accumulation ratio based on Cmax,ss (RA,Cmax). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00. | Up to 504 hours following first drug administration, Please find the time frame in description section. |
| Part 2 (MRD) - Accumulation Ratio Based on AUC0-tau (RA,AUC) | Part 2 (MRD) - Accumulation ratio based on AUC0-tau (RA,AUC). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00. | Up to 324 hours following first drug administration, Please find the time frame in description section. |
Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14
| FG002 | BI 1015550 36 milligram (mg) Single Dose (SD) | Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
| FG003 | BI 1015550 48 milligram (mg) Single Dose (SD) | Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
| FG004 | BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) | Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
| FG005 | BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) | Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
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| NOT COMPLETED |
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Treated set (TS): This subject set included all subjects who had received at least 1 dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Single Dose (SD) | Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
| BG001 | Placebo Multiple Dose (MD) | Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
| BG002 | BI 1015550 36 Milligram (mg) Single Dose (SD) | Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
| BG003 | BI 1015550 48 Milligram (mg) Single Dose (SD) | Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 |
| BG004 | BI 1015550 6 Milligram (mg) Twice Daily Multiple Dose (MD) | Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
| BG005 | BI 1015550 12 Milligram (mg) Twice Daily Multiple Dose (MD) | Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 |
| BG006 | 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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| Race (NIH/OMB) | Ethnicity was not reported in this trial. | 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 | |||||||||||||||||||||||||||||||||||
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| Primary | Number of Subjects With Drug-related Adverse Events (AEs) | Number of subjects with drug-related Adverse Events (AEs). | Treated Set | Posted | Count of Participants | Participants | For SRD: From the administration of study medication until 7 days, up to day 8. For MRD: From the first administration of study medication until 7 days after the last administration of study medication, i.e. up to 21 days after first drug administration. |
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| Secondary | Part 1 (SRD): Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Part 1 (SRD): Area under the concentration-time curve of the BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole*hour/liter (nmol∙h/L) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration |
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| Secondary | Part 1 (SRD): Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | Part 1 (SRD): Maximum measured concentration of the BI 1015550 in plasma (Cmax). | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/liter (nmol/L) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration |
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| Secondary | Part 2 (MRD) - After the First Dose : Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCτ,1) | Part 2 (MRD) - After the first dose : Area under the concentration-time curve of the BI 1015550 in plasma over a uniform dosing interval tau after administration of the first dose (AUCτ,1). | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole*hour/liter (nmol∙h/L) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration |
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| Secondary | Part 2 (MRD) - After the First Dose : Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | Part 2 (MRD) - After the first dose : Maximum measured concentration of the BI 1015550 in plasma (Cmax). | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/liter (nmol/L) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration |
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| Secondary | Part 2 (MRD) - After the Last Dose: Area Under the Concentration-time Curve of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss) | Part 2 (MRD) - After the last dose: Area under the concentration-time curve of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss). | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole*hour/liter (nmol∙h/L) | Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 311:55, 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00 |
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| Secondary | Part 2 (MRD) - After the Last Dose: Maximum Measured Concentration of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax,ss) | Part 2 (MRD) - After the last dose: Maximum measured concentration of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (Cmax,ss). | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/liter (nmol/L) | Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00 |
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| Secondary | Part 2 (MRD) - Accumulation Ratio Based on Cmax,ss (RA,Cmax) | Part 2 (MRD) - Accumulation ratio based on Cmax,ss (RA,Cmax). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00. | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Up to 504 hours following first drug administration, Please find the time frame in description section. |
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| Secondary | Part 2 (MRD) - Accumulation Ratio Based on AUC0-tau (RA,AUC) | Part 2 (MRD) - Accumulation ratio based on AUC0-tau (RA,AUC). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00. | Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Up to 324 hours following first drug administration, Please find the time frame in description section. |
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Adverse events: For SRD: From the administration of study medication until 7 days, up to day 8. For MRD: From the first administration of study medication until 7 days after the last administration of study medication, i.e. up to 21 days after first drug administration. All-cause mortality: for SRD, up to 9 days, for MRD, up to 28 days.
Treated set (TS): This subject set included all subjects who had received at least 1 dose of trial medication.
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 | Placebo Single Dose (SD) | Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | Placebo Multiple Dose (MD) | Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | BI 1015550 36 milligram (mg) Single Dose (SD) | Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | BI 1015550 48 milligram (mg) Single Dose (SD) | Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) | Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 | 0 | 8 | 0 | 8 | 2 | 8 |
| EG005 | BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) | Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 | 0 | 8 | 0 | 8 | 5 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Occult blood positive | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 20.1 | 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 | Apr 11, 2018 | Oct 17, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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| Male |
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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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