Clinical trial
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075…
NCT01688830 · Boehringer Ingelheim, Industry · Completed
Key facts
| NCT number | NCT01688830 |
|---|---|
| Title | Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate |
| Official title | 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) |
| Lead sponsor | Boehringer Ingelheim, Industry |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Healthy |
| Intervention type | Drug |
| Interventions | Dabigatran, BI 655075, Placebo |
| Enrollment | 157 |
| Start date | Sep 1, 2012 |
| Primary completion | Nov 1, 2013 |
| Completion | Nov 1, 2013 |
| First posted | Sep 20, 2012 |
| Last update posted | Jun 23, 2016 |
| Countries | Belgium |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: