Completed PHASE1 INTERVENTIONAL 3-arm NCT01688830

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

Randomised, Double-blind, Placebo-controlled Phase I Study in Healthy Male Volunteers. to Investigate Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 655075 (Part 1) and to Explore the Dose of BI 655075 Effective to Reverse Dabigatran Anticoagulant Activity (Part 2)

Sponsor: Boehringer Ingelheim

Conditions Healthy

Interventions BI 655075 Dabigatran Placebo

Updated 7 times since 2017 Last updated: May 20, 2016 Started: Sep 30, 2012 Primary completion: Nov 30, 2013 Completion: Nov 30, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Healthy, this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 7 data snapshots since 2012. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Sep 2025 [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Dec 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Dec 2021 [monthly]

Completed PHASE1

▶ Show 2 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Sep 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Boehringer Ingelheim

Data source: Boehringer Ingelheim

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Antwerp, Belgium