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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005614-19 | EudraCT Number | EudraCT |
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To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo to BI 1015550 | Experimental | placebo |
|
| BI 1015550 low dose 1 | Experimental | powder for oral solution |
|
| BI 1015550 low dose 2 | Experimental | powder for oral solution |
|
| BI 1015550 medium dose 1 | Experimental | powder for oral solution |
|
| BI 1015550 medium dose 2 | Experimental | powder for oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo to BI 1015550 |
| |
| BI 1015550 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug related Adverse events, as assessed by the investigator. | From first drug administration until last drug administration, upto 18 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum measured concentration of BI 1015550 in plasma. | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. |
| AUCt,1 |
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Inclusion criteria:
1. Healthy male subjects
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1305.2.1 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
This study of multiple doses over 14 days was randomised, double-blind, and placebo-controlled within dose groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo to BI 1015550 | Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group. |
| FG001 | 1 mg BI 1015550 | Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total). |
| FG002 | 6 mg BI 1015550 | Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo to BI 1015550 | Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group. |
| BG001 | 1 mg BI 1015550 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug related Adverse events, as assessed by the investigator. | The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. | Posted | Number | Percentage of participants | From first drug administration until last drug administration, upto 18 days. |
|
From first drug administration until last drug administration, upto 18 days.
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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 | Placebo to BI 1015550 | Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 17.1 | Systematic Assessment |
The study was prematurely completed as per protocol after 2 of the originally planned 4 dose groups ie., 1 mg BI 1015550 and 6 mg BI 1015550 because of higher than expected drug exposure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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| Drug |
medium dose 1 powder for oral solution |
|
| BI 1015550 | Drug | medium dose 2 powder for oral solution |
|
| BI1015550 | Drug | low dose 2 powder for oral solution |
|
| BI 1015550 | Drug | low dose 1 powder for oral solution |
|
Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose
| 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration |
| AUC0-infinity | Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity. | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. |
| Cmax,ss | Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t. | 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h. |
| AUCt,ss | Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t. | 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h. |
Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total). |
| BG002 | 6 mg BI 1015550 | Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
| OG002 | 6 mg BI 1015550 | Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total). |
|
|
| Secondary | Cmax | Maximum measured concentration of BI 1015550 in plasma. | The PK analysis set (PKS) included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint and who did not have a protocol violation relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. |
|
|
|
| Secondary | AUCt,1 | Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration |
|
|
|
| Secondary | AUC0-infinity | Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. |
|
|
|
| Secondary | Cmax,ss | Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h. |
|
|
|
| Secondary | AUCt,ss | Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h. |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | 1 mg BI 1015550 | Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total). | 0 | 9 | 4 | 9 |
| EG002 | 6 mg BI 1015550 | Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total). | 0 | 9 | 1 | 9 |
| Abdominal pain lower | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 17.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | 17.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | 17.1 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | 17.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 17.1 | Systematic Assessment |
|
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