NCT01688830

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
157

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2012

Longer than P75 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

September 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 15, 2016

Completed
Last Updated

June 23, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

September 17, 2012

Results QC Date

November 13, 2015

Last Update Submit

May 20, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Drug Related Adverse Events (AE)

    Frequency of subjects with related adverse events (AE) by treatment

    AEs occurring until end of follow-up (Up to 3 months after last drug administration)

Secondary Outcomes (9)

  • Cmax (Maximum Measured Concentration) for Idarucizumab

    -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  • Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab

    -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  • AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab

    -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  • Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)

    Up to 7 hours

  • Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran

    Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment

  • +4 more secondary outcomes

Study Arms (3)

BI 655075

EXPERIMENTAL
Drug: BI 655075

Placebo

PLACEBO COMPARATOR
Drug: Placebo

BI 655075 with dabigatran

EXPERIMENTAL
Drug: DabigatranDrug: BI 655075

Interventions

DabigatranDRUG
BI 655075 with dabigatran
BI 655075DRUG
BI 655075BI 655075 with dabigatran
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy 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)

1321.1.1 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

Related Publications (2)

  • 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

  • Glund S, Stangier J, Schmohl M, Gansser D, Norris S, van Ryn J, Lang B, Ramael S, Moschetti V, Gruenenfelder F, Reilly P, Kreuzer J. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015 Aug 15;386(9994):680-90. doi: 10.1016/S0140-6736(15)60732-2. Epub 2015 Jun 15.

    PMID: 26088268DERIVED

MeSH Terms

Interventions

Dabigatranidarucizumab

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

There is only one group of subjects in study part 3 receiving active treatment. However, AE table displays the AEs occurring in different phases separately.

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
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

September 17, 2012

First Posted

September 20, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

June 23, 2016

Results First Posted

February 15, 2016

Record last verified: 2016-05

Locations

BE(1)