CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Dabigatran etexilate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03086356
NCT03086356Phase 1Completed
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Open Label Phase I Trial in Healthy Chinese Male and Female Volunteers to Investigate Pharmacokinetics and Pharmacodynamics of Idarucizumab to Reverse Dabigatran Anticoagulant Activity

Boehringer Ingelheim·interventional·Posted Mar 22, 2017·Updated Mar 8, 2019

In Brief

A Phase 1 clinical trial evaluating Dabigatran etexilate and Idarucizumab for Healthy Volunteers. Completed, enrolled 12 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartMay 10, 2017
Primary CompletionSep 12, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.3 years ago

Interventions

Dabigatran etexilatedrug

Days 1-4 and Day 8-11

Idarucizumabdrug

Day 11