A Phase 1 interventional study of Dabigatran etexilate and Idarucizumab in Healthy Volunteers, sponsored by Boehringer Ingelheim. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The primary objective of the trial is to investigate the pharmacokinetics and pharmacodynamics of idarucizumab in Chinese healthy male and female subjects following intravenous administration of idarucizumab followed by idarucizumab with 15 minutes interval when administered at or close to the steady state of dabigatran.
Another objective of this trial is to explore the effect idarucizumab on the PK (pharmacokinetic(s)) and PD (pharmacodynamic) parameters of dabigatran.
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Dabigatran etexilate alone (days 1-4) and (days 8-10) and with Idarucizumab (day 11)
Drug: Dabigatran etexilate · Drug: Idarucizumab
Days 1-4 and Day 8-11
Also known as: PRADAXA, PRAZAXA
Day 11
Also known as: PRAXBIND, Praxbind, Prizbind
Maximum Measured Concentration of Idarucizumab in Plasma (Cmax)
Cmax, maximum measured concentration of idarucizumab in plasma
Time frame: -0.017, 0.083, 0.167, 0.317, 0.417, 0.45, 0.583, 0.917, 1.417, 2.083, 3.083, 4.083, 6.083, 10.083, 12.083, 24.083, 48.083, 72.083 hours (h)
For Diluted Thrombin Time: Area After Subtraction of Baseline Area From Area Under the Effect Curve Over the Time Interval From 2 - 12 Hours (AUEC Above,2-12) on Day 4 and Day 11
For diluted thrombin time: AUEC above,2-12 (area after subtraction of baseline area from area under the effect curve over the time interval from 2 - 12) on day 4 and day 11. The standard deviation (SD) presented is actually the percentage coefficient of variation (CV %)
Time frame: Day 4 and day 11
Area Under the Concentration-time Curve of Idarucizumab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
AUC0-∞, area under the concentration-time curve of idarucizumab in plasma over the time interval from 0 extrapolated to infinity
Time frame: -0.017, 0.083, 0.167, 0.317, 0.417, 0.45, 0.583, 0.917, 1.417, 2.083, 3.083, 4.083, 6.083, 10.083, 12.083, 24.083, 48.083, 72.083 hours (h)
Amount of Idarucizumab Eliminated in Urine Over the Time Interval From 0 to 72 Hours (h) (Ae0-72)
Ae0-72, amount of idarucizumab eliminated in urine over the time interval from 0 to 72 h. As per the protocol, day is counted as "Day 1 = 0:00"
Time frame: 0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4
For Sum Dabigatran: Amount of the Analyte Excreted in Urine at Steady State Over the Time Interval 0-74 Hours (Ae0-74,ss ) on Day 4 and Day 11
For sum dabigatran: Ae0-74,ss (amount of the analyte excreted in urine at steady state over the time interval 0-74) on day 4 and day 11 if feasible. As per the protocol, day is counted as "Day 1 = 0:00"
Time frame: 0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.
For Unbound Sum Dabigatran: Area Under the Concentration-time Curve of the Dabigatran in Plasma at Steady State Over the Time Interval 2 Hours-12 Hours
For unbound sum dabigatran: AUC 2-12,ss (Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours). As per the protocol, day is counted as "Day 1 = 0:00".
Time frame: Day 4: 74h, 74.5h, 75h, 76h, 78h, 80h, 84h; Day 11: 242h, 242.083h, 242.25h, 242.333h 243.333h, 244h, 246h, 248h, 252h
This was a single-centre, open-label trial in 1 group of healthy volunteers. The trial included a 2-week treatment period during which the subjects were hospitalised at the trial site and a follow-up period of approximately 3 months.
| Milestone | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
Cmax, maximum measured concentration of idarucizumab in plasma
| nanomoles (nmol) per litre (L) | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Maximum Measured Concentration of Idarucizumab in Plasma (Cmax) | 30900 ± 9.86 |
For diluted thrombin time: AUEC above,2-12 (area after subtraction of baseline area from area under the effect curve over the time interval from 2 - 12) on day 4 and day 11. The standard deviation (SD) presented is actually the percentage coefficient of variation (CV %)
| hours | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Day 4 | 8.23 ± 32.0 |
| Day 11 | 0.118 ± 140 |
For sum dabigatran: Ae0-74,ss (amount of the analyte excreted in urine at steady state over the time interval 0-74) on day 4 and day 11 if feasible. As per the protocol, day is counted as "Day 1 = 0:00"
| μg (microgram) | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Day 4 | 11700 ± 30.0 |
| Day 11 | 11000 ± 41.8 |
For unbound sum dabigatran: AUC 2-12,ss (Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours). As per the protocol, day is counted as "Day 1 = 0:00".
| nanograms*hours/ milliliter | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Day 4 | 1270 ± 37.0 |
| Day 11 | 11.6 ± 44.3 |
AUC0-∞, area under the concentration-time curve of idarucizumab in plasma over the time interval from 0 extrapolated to infinity
| nanomoles (nmol)*hours (h) per litre (L) | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Area Under the Concentration-time Curve of Idarucizumab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 44200 ± 10.1 |
Ae0-72, amount of idarucizumab eliminated in urine over the time interval from 0 to 72 h. As per the protocol, day is counted as "Day 1 = 0:00"
| micromole (μmol) | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Amount of Idarucizumab Eliminated in Urine Over the Time Interval From 0 to 72 Hours (h) (Ae0-72) | 35.3 ± 57.1 |
Collected over Adverse events from the first intake of treatment until the end of treatment visit; up to 23 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dabigatran Etexilate+Idarucizumab | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Event | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Albumin urine presentInvestigations | 12/12 |
| Alpha 1 microglobulin increasedInvestigations | 12/12 |
| Protein urine presentInvestigations | 11/12 |
| Activated partial thromboplastin time prolongedInvestigations | 10/12 |
| Urine electrophoresis abnormalInvestigations | 10/12 |
| Prothrombin level decreasedInvestigations | 4/12 |
| HaematomaVascular disorders | 1/12 |
| DiarrhoeaGastrointestinal disorders | 1/12 |
| Blood triglycerides increasedInvestigations | 1/12 |
Treated set (TS): The TS included all subjects who received at least 1 infusion of idarucizumab.
| Age, Continuous(years) | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Mean | 35.6 ± 5.8 |
| Sex: Female, Male(Participants) | Dabigatran Etexilate+Idarucizumab |
|---|---|
| Female | 6 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Dabigatran Etexilate+Idarucizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 12 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Boehringer Ingelheim