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Trial record 1 of 5 for:    BI 655075
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Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate

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ClinicalTrials.gov Identifier: NCT01688830
Recruitment Status : Completed
First Posted : September 20, 2012
Results First Posted : February 15, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran Drug: BI 655075 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : September 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 655075 Drug: BI 655075
Placebo Comparator: Placebo Drug: Placebo
Experimental: BI 655075 with dabigatran Drug: Dabigatran
Drug: BI 655075



Primary Outcome Measures :
  1. 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) ]
    Frequency of subjects with related adverse events (AE) by treatment


Secondary Outcome Measures :
  1. 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 ]
    Cmax (maximum measured concentration) for idarucizumab

  2. 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 ]
    tmax (time from dosing to maximum measured concentration) for idarucizumab

  3. 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 ]
    AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab

  4. Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2) [ Time Frame: Up to 7 hours ]

    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.


  5. 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 ]

    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


  6. 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 ]

    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.


  7. 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 ]
    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

  8. 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 ]

    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)


  9. 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 ]

    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)




Information from the National Library of Medicine

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

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688830


Locations
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Belgium
1321.1.1 Boehringer Ingelheim Investigational Site
Antwerpen, Belgium
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01688830    
Other Study ID Numbers: 1321.1
2012-003611-66 ( EudraCT Number: EudraCT )
First Posted: September 20, 2012    Key Record Dates
Results First Posted: February 15, 2016
Last Update Posted: June 23, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants