Phase 1
Completed N=157
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
Healthy
Source: ClinicalTrials.gov NCT01688830 ↗
Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Number of Subjects With Drug Related Adverse Events (AE) — 2; 0; 0; 0 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 Number of Subjects With Drug Related Adverse Events (AE) |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax (Maximum Measured Concentration) for Idarucizumab |
79.9; 257; 809; 2440; 4520; 7420 | — |
| SECONDARY Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab |
1.00; 1.03; 1.03; 1.10; 0.967; 0.984 | — |
| SECONDARY AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab |
146; 426; 1950; 6970; 8780; 14500 | — |
| SECONDARY Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY 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 |
6600; 6870; 5160; 3820; 3860; 6420 | — |
| SECONDARY C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State) |
119; 136; 96.2; 135; 101; 112 | — |
| SECONDARY 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 |
805; 754; 161; 20.9; 11.9; 786 | — |
| SECONDARY 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 |
1.28; 0.46; 0.14; 0.07; 1.01; 0.26 | — |
| SECONDARY 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 |
1.68; 0.03; 1.02; 0.01 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01688830). 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.