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Trial record 2 of 4 for:    BI 655075

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01688830
First received: September 17, 2012
Last updated: May 20, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Healthy
Drug: Dabigatran
Drug: BI 655075
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Phase I Study in Healthy Male Volunteers. to Investigate Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 655075 (Part 1) and to Explore the Dose of BI 655075 Effective to Reverse Dabigatran Anticoagulant Activity (Part 2)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Subjects With Drug Related Adverse Events (AE) [ Time Frame: AEs occurring until end of follow-up (Up to 3 months after last drug administration) ] [ Designated as safety issue: No ]
    Frequency of subjects with related adverse events (AE) by treatment


Secondary Outcome Measures:
  • Cmax (Maximum Measured Concentration) for Idarucizumab [ Time Frame: -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 ] [ Designated as safety issue: No ]
    Cmax (maximum measured concentration) for idarucizumab

  • Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab [ Time Frame: -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 ] [ Designated as safety issue: No ]
    tmax (time from dosing to maximum measured concentration) for idarucizumab

  • AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab [ Time Frame: -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 ] [ Designated as safety issue: No ]
    AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab

  • Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2) [ Time Frame: Up to 7 hours ] [ Designated as safety issue: No ]

    Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)

    Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion.


  • 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 [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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

    Ae(0-12h,ss) of sum dabigatran


  • C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State) [ Time Frame: 1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4 ] [ Designated as safety issue: No ]

    Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.

    The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). "BLQ" values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.


  • AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 [ Time Frame: 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h ] [ Designated as safety issue: No ]
    AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4

  • AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study [ Time Frame: 2hours-12 hours ] [ Designated as safety issue: No ]

    AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).

    Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.

    This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)


  • AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study [ Time Frame: 2hours-12 hours ] [ Designated as safety issue: No ]

    AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).

    Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.

    This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)



Enrollment: 157
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 655075 Drug: BI 655075
Placebo Comparator: Placebo Drug: Placebo
Experimental: BI 655075 with dabigatran Drug: Dabigatran Drug: BI 655075

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688830

Locations
Belgium
1321.1.1 Boehringer Ingelheim Investigational Site
Antwerpen, Belgium
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01688830     History of Changes
Other Study ID Numbers: 1321.1  2012-003611-66 
Study First Received: September 17, 2012
Results First Received: November 13, 2015
Last Updated: May 20, 2016
Health Authority: Belgium: Federal Agency for Medicinal and Health Products

Additional relevant MeSH terms:
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on September 29, 2016