Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: dabigatran; Drug: Placebo to Idarucizumab; Drug: Placebo to dose; Drug: Idarucizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02028780

1321.5

Details and patient eligibility

About

The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.

Enrollment: 80 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy Japanese male subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Idarucizumab single doses

Experimental group

Description:

different infusion durations

Treatment:

Drug: Idarucizumab

Drug: Idarucizumab

Drug: Placebo to dose

Idarucizumab with dabigatran

Experimental group

Description:

short infusion with 2 capsules dabigatran

Treatment:

Drug: Placebo to Idarucizumab

Drug: Idarucizumab

Drug: Idarucizumab

Drug: dabigatran