Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Dabigatran; Drug: BI 655075

Study type: Interventional

Funder types: Industry

Identifiers

NCT01688830

1321.1

2012-003611-66 (EudraCT Number)

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: 157 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy 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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157 participants in 3 patient groups, including a placebo group

BI 655075

Experimental group

Treatment:

Drug: BI 655075

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BI 655075 with dabigatran

Experimental group

Treatment:

Drug: BI 655075

Drug: Dabigatran