NCT02028780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 11, 2016

Completed
Last Updated

February 11, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

January 6, 2014

Results QC Date

November 13, 2015

Last Update Submit

January 13, 2016

Conditions

Healthy

Outcome Measures

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.

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

Secondary Outcomes (7)

  • 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.

  • 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

  • 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

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Idarucizumab single doses

EXPERIMENTAL

different infusion durations

Drug: Placebo to doseDrug: Idarucizumab

Idarucizumab with dabigatran

EXPERIMENTAL

short infusion with 2 capsules dabigatran

Drug: IdarucizumabDrug: Placebo to IdarucizumabDrug: dabigatran

Interventions

Placebo to doseDRUG

placebo

Idarucizumab single doses
IdarucizumabDRUG

short infusion

Idarucizumab with dabigatran
Placebo to IdarucizumabDRUG

Placebo to Idarucizumab

Idarucizumab with dabigatran
dabigatranDRUG

2 capsules dabigatran

Idarucizumab with dabigatran

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy Japanese male subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1321.5.00001 Boehringer Ingelheim Investigational Site

Sumida-ku, Tokyo, Japan

Location

Related Publications (2)

  • 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.

    PMID: 30046691DERIVED

  • 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.

    PMID: 28230262DERIVED

MeSH Terms

Interventions

idarucizumabDabigatran

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 7, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 11, 2016

Results First Posted

February 11, 2016

Record last verified: 2016-01

Locations

JP(1)