Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State

Phase 1 Completed 12 enrolled Boehringer Ingelheim

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2017-05-10
Primary completion: 2017-09-12
Completion: 2017-09-12

Publications

Wang Z, Zhao X, He P, Chen S, Jiang J, Harada A, Brooks S, Cui Y. Idarucizumab Reverses Dabigatran Anticoagulant Activity in Healthy Chinese Volunteers: A Pharmacokinetics, Pharmacodynamics, and Safety Study. Adv Ther. 2020 Sep;37(9):3916-3928. doi: 10.1007/s12325-020-01439-2. Epub 2020 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dabigatran etexilate	Unknown	220 mg	Oral
Subject	Idarucizumab	Monoclonal antibody	2.5 g	Intravenous

Indications

No indication recorded.