A total of 46 male and female volunteers ranging from 45 to 80 years of age were included in the randomized, double-blind, placebo-controlled cross-over trial.
The company said that all doses of idarucizumab were found to be well tolerated in healthy volunteers who were middle-aged (45-64 years) or elderly (65-80 years), or volunteers with mild or moderate kidney impairment.
Additionally, anticoagulation was restored when volunteers were re-dosed with dabigatran 24 hours after idarucizumab was administered.
A second administration of idarucizumab also showed that anticoagulation reversal was comparable to the results observed in the first administration.
During the trial, the volunteers aged 45-80 years were given a high dose of dabigatran 220mg twice daily for three days, and 150mg twice daily to those with mild or moderate kidney impairment, with one final dose given on the fourth day.
Boehringer Ingelheim vice president Medicine Therapeutic Area Cardiovascular professor Jörg Kreuzer said: "These results showed that idarucizumab consistently reversed the anticoagulant effects of dabigatran in adults independent of gender, age and kidney function, complementing data previously reported from younger, healthy male volunteers.
"Our findings show that the antidote’s effects remain consistent following a second administration and also that anticoagulation from dabigatran can be successfully restored 24 hours after idarucizumab is given."
The company is developing idarucizumab as a highly specific and selective antidote to Pradaxa to add a reversal option for physicians.