Phase 1
Completed N=80
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT02028780 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2 — 16.7; 0.0; 0.0; 0.0 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2 |
16.7; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II) |
9250; 12800; 11700; 8810; 11000; 9690 | — |
| SECONDARY AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II). |
909; 1260; 1010; 802; 1100; 909 | — |
| SECONDARY Cmax for Idarucizumab in the Part I & Part II. |
6810; 15700; 28100; 37600; 9510; 17600 | — |
| SECONDARY AUC0-inf for Idarucizumab in the Part I & Part II. |
9150; 19500; 37600; 76800; 8590; 19200 | — |
| SECONDARY Ae0-72 for Idarucizumab in the Part I & Part II. |
1.54; 6.10; 20.5; 4.21; 13.8; 42.6 | — |
| SECONDARY Ae0-73 for the Dose Group 4 in the Part I |
69.1 | — |
| SECONDARY AUEC2-12 |
16.3; 18.0; 17.4; 15.5; 17.3; 15.8 | — |
Eligibility Criteria
Inclusion criteria
- Healthy Japanese male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT02028780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.