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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo to dose; Drug: Placebo to Idarucizumab; Drug: Idarucizumab; Drug: dabigatran

• Registration Number: NCT02028780
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-11-13
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-13
• Last Update Submitted: 2016-01-13
• Results First Posted: 2016-02-11
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Idarucizumab with dabigatran	Placebo to Idarucizumab	short infusion with 2 capsules dabigatran
Idarucizumab single doses	Placebo to dose	different infusion durations
Idarucizumab single doses	Idarucizumab	different infusion durations
Idarucizumab with dabigatran	Idarucizumab	short infusion with 2 capsules dabigatran
Idarucizumab with dabigatran	dabigatran	short infusion with 2 capsules dabigatran

Primary Outcome Measures

Name	Time	Method
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)	Percentage of subjects with drug-related adverse events in Part 1 and Part 2.

Secondary Outcome Measures

Name	Time	Method
Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II)	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.
Cmax for Idarucizumab in the Part I & Part II.	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.	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.
AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).	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.
AUEC2-12	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 \[h\].
Ae0-73 for the Dose Group 4 in the Part I	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
Ae0-72 for Idarucizumab in the Part I & Part II.	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.

Trial Locations

Locations (1)

1321.5.00001 Boehringer Ingelheim Investigational Site; 🇯🇵 Sumida-ku, Tokyo, Japan