Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02028780
Recruitment Status : Completed
First Posted : January 7, 2014
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE January 6, 2014
First Posted Date  ICMJE January 7, 2014
Results First Submitted Date  ICMJE November 13, 2015
Results First Posted Date  ICMJE February 11, 2016
Last Update Posted Date February 11, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
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) ]
Percentage of subjects with drug-related adverse events in Part 1 and Part 2.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
The number (%) of subjects with drug-related adverse events in Part 1 and Part 2 [ Time Frame: up to 108 days ]
Change History Complete list of historical versions of study NCT02028780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Ae0−74,ss on Days 4 and 11 for Sum Dabigatran (Part II) [ 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. ]
    Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours.
  • AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II). [ Time Frame: Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section ]
    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.
  • Cmax for Idarucizumab in the Part I & Part II. [ 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 ]
    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.
  • AUC0-inf for Idarucizumab in the Part I & Part II. [ 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 ]
    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.
  • Ae0-72 for Idarucizumab in the Part I & Part II. [ 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 ]
    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.
  • Ae0-73 for the Dose Group 4 in the Part I [ Time Frame: For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h ]
    Amount of the analyte excreted in urine over the time interval 0-73
  • AUEC2-12 [ Time Frame: Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section ]
    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].
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
  • sum dabigatran: Ae0-72 in Part 2 [ Time Frame: from Day 4 to Day 7 ]
  • sum dabigatran: Ae0-72 in Part 2 [ Time Frame: from Day 11 to Day 14 ]
  • unbound sum dabigatran: AUC2-12 (area under the concentration-time curve of the analyte in plasma over the time interval from 2 hour - 72 hour) in Part 2 [ Time Frame: from Day 4 to Day 7 ]
  • unbound sum dabigatran: AUC2-12 in Part 2 [ Time Frame: from Day 11 to Day 14 ]
  • dTT (diluted thrombin time): AUEC2-12 in Part 2 [ Time Frame: from Day 4 to Day 7 ]
  • dTT: AUEC2-12 in Part 2 [ Time Frame: from Day 11 to Day 14 ]
  • BI 655075: Cmax (maximum measured concentration of the analyte in plasma) in Part 1 and Part 2 [ Time Frame: up to 14 days ]
  • BI 655075: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) in Part 1 and Part 2 [ Time Frame: up to 14 days ]
  • BI 655075: Ae0-72 (amount of the analyte excreted in urine over the time interval from 0 to 72 hour) in Part 1 and Part 2 [ Time Frame: up to 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
Official Title  ICMJE Randomised, Double-blind Within Dose Groups, Placebo-controlled Phase I Trial in Healthy Japanese Male Volunteers to Investigate Safety, Tolerability and Pharmacokinetics of Different Doses of BI 655075 (Part 1) and to Explore the Effective Dose of BI 655075 to Reverse Dabigatran Anticoagulant Activity (Part 2).
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Placebo to dose
    placebo
  • Drug: Idarucizumab
    short infusion
  • Drug: Placebo to Idarucizumab
    Placebo to Idarucizumab
  • Drug: dabigatran
    2 capsules dabigatran
Study Arms  ICMJE
  • Experimental: Idarucizumab single doses
    different infusion durations
    Interventions:
    • Drug: Placebo to dose
    • Drug: Idarucizumab
  • Experimental: Idarucizumab with dabigatran
    short infusion with 2 capsules dabigatran
    Interventions:
    • Drug: Idarucizumab
    • Drug: Placebo to Idarucizumab
    • Drug: dabigatran
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

1. Healthy Japanese male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02028780
Other Study ID Numbers  ICMJE 1321.5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP