Phase 1
N=46
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT01955720 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time — 0.0; 100.0; 0.0; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 655075 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time |
0.0; 100.0; 0.0; 100.0; 0.0; 100.0 | — |
| PRIMARY The Percentage of Subjects With Drug-related Adverse Events |
13.0 | — |
| SECONDARY AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity) |
22200; 20600; 37000; 8560; 43900; 10700 | — |
| SECONDARY AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h) |
18.5; 924; 36.0; 10.6; 933; 284 | — |
| SECONDARY Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2) |
6080; 7460; 7560; 7790; 8490; 8870 | — |
| SECONDARY Cmax (Maximum Measured Concentration of the Ida in Plasma) |
15700; 14900; 25000; 5790; 28300; 6940 | — |
| SECONDARY Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h) |
13.5; 33.5; 1.97; 41.6; 2.60; 33.4 | — |
Summary
To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran
Eligibility Criteria
Inclusion criteria
- Healthy midage male and female volunteers, age =45 and =64 years, BMI range: =18.5 and =29.9 kg/m2
- Healthy elderly male and female volunteers, age =65 and =80 years, BMI range: =18.5 and = 32 kg/m2
- Male and female volunteers with mild renal impairment (CLcrd 60-90 (mL/min)) in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2 Moderate renal impaired (CLcrd =30 to <60 mL/min according Cockcroft&Gault formula in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2
Exclusion criteria
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease (other than mild renal impairment in the respective group) A significant disease is defined as a disease which in the opinion of the investigator
- put the volunteer at risk because of participation in the study
- may influence the results of the study
- may influence the volunteer¿s ability to participate in the study
- is not in a stable condition Diabetic, hypercholesterolemia or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Data sourced from ClinicalTrials.gov (NCT01955720). 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.