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The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idarucizumab single doses | Experimental | different infusion durations |
|
| Idarucizumab with dabigatran | Experimental | short infusion with 2 capsules dabigatran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to dose | Drug | placebo |
| |
| Idarucizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2 | Percentage of subjects with drug-related adverse events in Part 1 and Part 2. | From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II) |
| Measure | Description | Time Frame |
|---|---|---|
| Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II) | Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours. | 0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11. |
| AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II). |
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Inclusion criteria:
1. Healthy Japanese male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1321.5.00001 Boehringer Ingelheim Investigational Site | Sumida-ku, Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30046691 | Derived | Yasaka M, Ikushima I, Harada A, Imazu S, Taniguchi A, Norris S, Gansser D, Stangier J, Schmohl M, Reilly PA. Safety, pharmacokinetics and pharmacodynamics of idarucizumab, a specific dabigatran reversal agent in healthy Japanese volunteers: a randomized study. Res Pract Thromb Haemost. 2017 Aug 5;1(2):202-215. doi: 10.1002/rth2.12029. eCollection 2017 Oct. | |
| 28230262 |
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Randomised, double-blind within dose groups, placebo controlled, sequential rising order, single centre trial. This study has two phases ie., Observation phase (Single administration of placebo or BI study drug and 6-14 days follow up) and Follow up phase (End of observation phase to 92-98 days after administration of Placebo or BI study drug).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo_5m (Part I) | Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1. |
| FG001 | Placebo_1h (Part I) | Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Observation Phase |
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| Drug |
short infusion |
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| Placebo to Idarucizumab | Drug | Placebo to Idarucizumab |
|
| dabigatran | Drug | 2 capsules dabigatran |
|
| Idarucizumab | Drug | short infusion |
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Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours. Time Frame: For dose group 5 to 7 (Day 1 to 3-Part-I):74hours (h), 74.5h, 75h, 76h, 78h, 80h, 82h, 84h, For dose group 8 (Day 1 to 3-Part-I): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h and For dose group 5-7 (Day11 to Day13-Part II):242h, 242.167h, 242.5h, 243h, 244h,246h, 248h, 250h, 252h. For dose group 8 (Day11 to Day13-Part II):242h, 242.083h, 242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h. |
| Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section |
| Cmax for Idarucizumab in the Part I & Part II. | Maximum measured concentration of the analyte in plasma for idarucizumab Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, -0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h. | Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section |
| AUC0-inf for Idarucizumab in the Part I & Part II. | Area under the concentration-time curve of the analyte in plasma for idarucizumab over the time interval from 0 extrapolated to infinity. Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, -0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h. | Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section |
| Ae0-72 for Idarucizumab in the Part I & Part II. | Amount of idarucizumab eliminated in urine over the time interval 0-72. Time frame: For dose groups 1 to 3 (day1 to day4-Part-1):0-4 h, 4-8 h, 8-12 h, 12-24 h, 24-48 h, 48-72 h. For dose groups 5 to 7 (day 11 to day14-Part-II): 0-4 h, 4-8 h, 8-10 h, 10-12 h,12-24 h, 24-48 h, and 48-72 h. For dose groups 8 (day11 to day14-Part-II): 0-4h, 4-8 h, 8-10 h, 10-24 h, 24-48 h, 48-72 h. | Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section |
| Ae0-73 for the Dose Group 4 in the Part I | Amount of the analyte excreted in urine over the time interval 0-73 | For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h |
| AUEC2-12 | Area under the effect curve over the time interval from 2 to 12h, AUEC2-12 on Days 4 and 11 for diluted thrombin time (dTT). For dose groups 5 to 7(day4-Part-II): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h on day 4. For dose groups 5 to 7(day11-Part-II): 242h, 242.083h, 242.167h, 242.5h, 243h, 244h, 246h, 248h, 250h, 252h. For dose groups 8(day4-Part-II): 74.5 h, 78 h, 84 h on day 4. For dose groups 8(day11-Part-II): 242h, 242.083h,242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h on day 11. AUEC is calculated by multiplying the ratio (Value at each time point/Ebase, unit of Vaue is [s] and Ebase is value [s] at baseline) by time. Therefore, Unit for AUEC2-12 is [h]. | Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section |
| Norris S, Ramael S, Ikushima I, Haazen W, Harada A, Moschetti V, Imazu S, Reilly PA, Lang B, Stangier J, Glund S. Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies. Br J Clin Pharmacol. 2017 Aug;83(8):1815-1825. doi: 10.1111/bcp.13269. Epub 2017 Apr 6. |
| FG002 | BI1000mg_5m (Dose group1 - Part I) | Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1. |
| FG003 | BI2000mg_5m (Dose group2 - Part I) | Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1. |
| FG004 | BI4000mg_5m (Dose group3 - Part I) | Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1. |
| FG005 | BI8000mg_1h (Dose group4 - Part I) | Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1. |
| FG006 | DE+Placebo_5m (Part II) | Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11. |
| FG007 | DE+Placebo+Placebo (Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| FG008 | DE+1000mg_5m (Dose group5 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| FG009 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| FG010 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| FG011 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| COMPLETED |
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| NOT COMPLETED |
|
| Follow up Phase |
|
Treated Set (TS): : This subject set included all subjects who received the idarucizumab or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo_5m (Part I) | Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1. |
| BG001 | Placebo_1h (Part I) | Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1. |
| BG002 | BI1000mg_5m (Dose group1 - Part I) | Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1. |
| BG003 | BI2000mg_5m (Dose group2 - Part I) | Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1. |
| BG004 | BI4000mg_5m (Dose group3 - Part I) | Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1. |
| BG005 | BI8000mg_1h (Dose group4 - Part I) | Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1. |
| BG006 | DE+Placebo_5m (Part II) | Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11. |
| BG007 | DE+Placebo+Placebo (Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| BG008 | DE+1000mg_5m (Dose group5 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| BG009 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| BG010 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| BG011 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| BG012 | 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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| 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 | Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2 | Percentage of subjects with drug-related adverse events in Part 1 and Part 2. | Treated set (TS) | Posted | Number | Percentage of participants | From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II) |
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| Secondary | Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II) | Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours. | PKS set: This subject set included all subjects who received the idarucizumab and who had at least one pharmacokinetic parameter. For the Part 2, subjects who had the emesis with onset at or before twice the median tmax of dabigatran were not included in this set. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg | 0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11. |
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| Secondary | AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II). | Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours. Time Frame: For dose group 5 to 7 (Day 1 to 3-Part-I):74hours (h), 74.5h, 75h, 76h, 78h, 80h, 82h, 84h, For dose group 8 (Day 1 to 3-Part-I): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h and For dose group 5-7 (Day11 to Day13-Part II):242h, 242.167h, 242.5h, 243h, 244h,246h, 248h, 250h, 252h. For dose group 8 (Day11 to Day13-Part II):242h, 242.083h, 242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h. | PKS set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section |
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| Secondary | Cmax for Idarucizumab in the Part I & Part II. | Maximum measured concentration of the analyte in plasma for idarucizumab Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, -0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h. | PKS set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section |
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| Secondary | AUC0-inf for Idarucizumab in the Part I & Part II. | Area under the concentration-time curve of the analyte in plasma for idarucizumab over the time interval from 0 extrapolated to infinity. Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, -0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h. | PKS set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section |
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| Secondary | Ae0-72 for Idarucizumab in the Part I & Part II. | Amount of idarucizumab eliminated in urine over the time interval 0-72. Time frame: For dose groups 1 to 3 (day1 to day4-Part-1):0-4 h, 4-8 h, 8-12 h, 12-24 h, 24-48 h, 48-72 h. For dose groups 5 to 7 (day 11 to day14-Part-II): 0-4 h, 4-8 h, 8-10 h, 10-12 h,12-24 h, 24-48 h, and 48-72 h. For dose groups 8 (day11 to day14-Part-II): 0-4h, 4-8 h, 8-10 h, 10-24 h, 24-48 h, 48-72 h. | PKS set. Ae 0-72 data is not available for BI8000mg_1h (Dose group 4 - Part I) due to longer infusion time resulting different urine collection interval. Instead, Ae 0-73 is presented for BI8000mg_1h as separate endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol | Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section |
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| Secondary | Ae0-73 for the Dose Group 4 in the Part I | Amount of the analyte excreted in urine over the time interval 0-73 | PKS set. The results from dose group 4 has been disclosed, because only dose group 4 had 1hr infusion, Ae 0-73 was reported, instead of Ae0-72. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol | For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h |
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| Secondary | AUEC2-12 | Area under the effect curve over the time interval from 2 to 12h, AUEC2-12 on Days 4 and 11 for diluted thrombin time (dTT). For dose groups 5 to 7(day4-Part-II): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h on day 4. For dose groups 5 to 7(day11-Part-II): 242h, 242.083h, 242.167h, 242.5h, 243h, 244h, 246h, 248h, 250h, 252h. For dose groups 8(day4-Part-II): 74.5 h, 78 h, 84 h on day 4. For dose groups 8(day11-Part-II): 242h, 242.083h,242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h on day 11. AUEC is calculated by multiplying the ratio (Value at each time point/Ebase, unit of Vaue is [s] and Ebase is value [s] at baseline) by time. Therefore, Unit for AUEC2-12 is [h]. | Pharmacodynamic set (PDS): The PDS comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment pharmacodynamic observation. | Posted | Mean | Standard Deviation | h | Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section |
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From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)
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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_5m (Part I) | Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1. | 0 | 6 | 1 | 6 | ||
| EG001 | Placebo_1h (Part I) | Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1. | 0 | 2 | 0 | 2 | ||
| EG002 | BI1000mg_5m (Dose group1 - Part I) | Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1. | 0 | 6 | 0 | 6 | ||
| EG003 | BI2000mg_5m (Dose group2 - Part I) | Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1. | 0 | 6 | 0 | 6 | ||
| EG004 | BI4000mg_5m (Dose group3 - Part I) | Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1. | 0 | 6 | 0 | 6 | ||
| EG005 | BI8000mg_1h (Dose group4 - Part I) | Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1. | 0 | 6 | 0 | 6 | ||
| EG006 | DE+Placebo_5m (Part II) | Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11. | 0 | 9 | 0 | 9 | ||
| EG007 | DE+Placebo+Placebo (Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. | 0 | 3 | 0 | 3 | ||
| EG008 | DE+1000mg_5m (Dose group5 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. | 0 | 9 | 0 | 9 | ||
| EG009 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. | 0 | 9 | 0 | 9 | ||
| EG010 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. | 0 | 9 | 0 | 9 | ||
| EG011 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. | 0 | 9 | 0 | 9 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
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 |
| ID | Term |
|---|---|
| C000594745 | idarucizumab |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| OG002 |
| DE+2000mg_5m (Dose group6 - Part II) |
Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG003 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG004 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
|
|
| OG002 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG003 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG004 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
|
|
| OG002 |
| BI4000mg_5m (Dose group3 - Part I) |
Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1. |
| OG003 | BI8000mg_1h (Dose group4 - Part I) | Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1. |
| OG004 | DE+1000mg_5m (Dose group5 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG005 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG006 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG007 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
|
|
| OG002 | BI4000mg_5m (Dose group3 - Part I) | Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1. |
| OG003 | BI8000mg_1h (Dose group4 - Part I) | Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1. |
| OG004 | DE+1000mg_5m (Dose group5 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG005 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG006 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG007 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
|
|
| OG003 | DE+1000mg_5m (Dose group5 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG004 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG005 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG006 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
|
|
|
| OG002 | DE+2000mg_5m (Dose group6 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG003 | DE+4000mg_5m (Dose group7 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
| OG004 | DE+2500mg+2500mg (Dose group8 - Part II) | Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11. |
|
|