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CompletedNCT02028780Updated Feb 11, 2016Results posted

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects

A Phase 1 interventional study of Placebo to dose and Idarucizumab in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-11.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy Japanese male subjects

Exclusion criteria

Exclusion criteria:

  1. Any relevant deviation from healthy conditions
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Idarucizumab single doses

    different infusion durations

    Drug: Placebo to dose · Drug: Idarucizumab

  • Experimental
    Idarucizumab with dabigatran

    short infusion with 2 capsules dabigatran

    Drug: Idarucizumab · Drug: Placebo to Idarucizumab · Drug: dabigatran

Interventions

  • DrugPlacebo to dose

    placebo

  • DrugIdarucizumab

    short infusion

  • DrugPlacebo to Idarucizumab

    Placebo to Idarucizumab

  • Drugdabigatran

    2 capsules dabigatran

  • DrugIdarucizumab

    short infusion

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)

Secondary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section

  3. 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.

    Time frame: Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section

  4. 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.

    Time frame: Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section

  5. 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.

    Time frame: Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section

  6. Ae0-73 for the Dose Group 4 in the Part I

    Amount of the analyte excreted in urine over the time interval 0-73

    Time frame: For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h

  7. 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 \[h\].

    Time frame: Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section

07

Results

Posted Feb 11, 2016

Participant flow

Observation Phase
Participant flow — Observation Phase
MilestonePlacebo_5m (Part I)Placebo_1h (Part I)BI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+Placebo_5m (Part II)DE+Placebo+Placebo (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Started626666939999
Completed626666939999
Not completed000000000000
Follow up Phase
Participant flow — Follow up Phase
MilestonePlacebo_5m (Part I)Placebo_1h (Part I)BI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+Placebo_5m (Part II)DE+Placebo+Placebo (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Started626666939999
Completed626666939999
Not completed000000000000

Outcome measures

PrimaryPercentage 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.

Time frame:
From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)
Reported as:
Number · Percentage of participants
Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2
Percentage of participantsPlacebo_5m (Part I)Placebo_1h (Part I)BI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+Placebo_5m (Part II)DE+Placebo+Placebo (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 216.70.00.00.00.00.00.00.00.00.00.00.0
SecondaryAe0-74,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.

Time frame:
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.
Reported as:
Geometric mean · μg
Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II)
μgDE+Placebo_5m (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Day 49250 ± 42.012800 ± 21.611700 ± 45.78810 ± 33.811000 ± 32.9
Day 119690 ± 27.712500 ± 32.013100 ± 30.19310 ± 41.010600 ± 28.1
SecondaryAUC2-12,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.

Time frame:
Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section
Reported as:
Geometric mean · ng*h/mL
AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).
ng*h/mLDE+Placebo_5m (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Day 4909 ± 56.21260 ± 25.01010 ± 54.1802 ± 46.81100 ± 25.6
Day 11909 ± 34.8330 ± 10982.2 ± 14910.1 ± 1.8610.0 ± 0.0213
SecondaryCmax 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.

Time frame:
Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section
Reported as:
Geometric mean · nmol/L
Cmax for Idarucizumab in the Part I & Part II.
nmol/LBI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Cmax for Idarucizumab in the Part I & Part II.6810 ± 10.115700 ± 10.928100 ± 14.337600 ± 6.889510 ± 33.817600 ± 16.830200 ± 17.730100 ± 11.5
SecondaryAUC0-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.

Time frame:
Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section
Reported as:
Geometric mean · nmol*h/L
AUC0-inf for Idarucizumab in the Part I & Part II.
nmol*h/LBI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
AUC0-inf for Idarucizumab in the Part I & Part II.9150 ± 15.019500 ± 17.837600 ± 14.476800 ± 14.88590 ± 14.219200 ± 18.534500 ± 16.643300 ± 8.25
SecondaryAe0-72 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.

Time frame:
Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section
Reported as:
Geometric mean · μmol
Ae0-72 for Idarucizumab in the Part I & Part II.
μmolBI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Ae0-72 for Idarucizumab in the Part I & Part II.1.54 ± 54.96.10 ± 16520.5 ± 52.44.21 ± 35.113.8 ± 12.542.6 ± 16.451.5 ± 18.1
SecondaryAe0-73 for the Dose Group 4 in the Part I

Amount of the analyte excreted in urine over the time interval 0-73

Time frame:
For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h
Reported as:
Geometric mean · μmol
Ae0-73 for the Dose Group 4 in the Part I
μmolBI8000mg_1h (Dose group4 - Part I)
Ae0-73 for the Dose Group 4 in the Part I69.1 ± 25.0
SecondaryAUEC2-12

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 \[h\].

Time frame:
Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section
Reported as:
Mean · h
AUEC2-12
hDE+Placebo_5m (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Day 416.3 ± 2.3018.0 ± 1.7917.4 ± 4.0015.5 ± 2.1717.3 ± 2.02
Day 1115.8 ± 1.9312.5 ± 1.7411.2 ± 2.239.95 ± 0.20610.0 ± 0.131

Adverse events

Collected over From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo_5m (Part I)—0/6 (0%)1/6 (16.7%)
Placebo_1h (Part I)—0/2 (0%)0/2 (0%)
BI1000mg_5m (Dose group1 - Part I)—0/6 (0%)0/6 (0%)
BI2000mg_5m (Dose group2 - Part I)—0/6 (0%)0/6 (0%)
BI4000mg_5m (Dose group3 - Part I)—0/6 (0%)0/6 (0%)
BI8000mg_1h (Dose group4 - Part I)—0/6 (0%)0/6 (0%)
DE+Placebo_5m (Part II)—0/9 (0%)0/9 (0%)
DE+Placebo+Placebo (Part II)—0/3 (0%)0/3 (0%)
DE+1000mg_5m (Dose group5 - Part II)—0/9 (0%)0/9 (0%)
DE+2000mg_5m (Dose group6 - Part II)—0/9 (0%)0/9 (0%)
DE+4000mg_5m (Dose group7 - Part II)—0/9 (0%)0/9 (0%)
DE+2500mg+2500mg (Dose group8 - Part II)—0/9 (0%)0/9 (0%)
Most frequent other events
Most frequent other events
EventPlacebo_5m (Part I)Placebo_1h (Part I)BI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+Placebo_5m (Part II)DE+Placebo+Placebo (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)
Blood creatine phosphokinase increasedInvestigations1/60/20/60/60/60/60/90/30/90/90/90/9

Baseline characteristics

Treated Set (TS): : This subject set included all subjects who received the idarucizumab or placebo.

Age, Continuous
Age, Continuous(Years)Placebo_5m (Part I)Placebo_1h (Part I)BI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+Placebo_5m (Part II)DE+Placebo+Placebo (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)Total
Mean28.7 ± 10.532.5 ± 4.931.5 ± 10.927.8 ± 7.731.5 ± 8.332.2 ± 8.124.7 ± 3.329.7 ± 5.023.8 ± 3.125.7 ± 3.125.4 ± 2.724.4 ± 1.427.3 ± 6.4
Sex: Female, Male
Sex: Female, Male(Participants)Placebo_5m (Part I)Placebo_1h (Part I)BI1000mg_5m (Dose group1 - Part I)BI2000mg_5m (Dose group2 - Part I)BI4000mg_5m (Dose group3 - Part I)BI8000mg_1h (Dose group4 - Part I)DE+Placebo_5m (Part II)DE+Placebo+Placebo (Part II)DE+1000mg_5m (Dose group5 - Part II)DE+2000mg_5m (Dose group6 - Part II)DE+4000mg_5m (Dose group7 - Part II)DE+2500mg+2500mg (Dose group8 - Part II)Total
Female0000000000000
Male62666693999980
08

Study locations

1 site
  • 1321.5.00001 Boehringer Ingelheim Investigational Site
    Sumida-ku, Tokyo, Japan
09

References and documents

Publications

  • 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. PubMed 30046691 ↗
  • 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. PubMed 28230262 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02028780
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jan 7, 2014
Start date
Jan 2014
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
Feb 11, 2016
Last update
Feb 11, 2016

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Boehringer Ingelheim

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