Clinical trial
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075…
NCT02028780 · Boehringer Ingelheim, Industry · Completed
Key facts
| NCT number | NCT02028780 |
|---|---|
| Title | Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects |
| Official title | Randomised, Double-blind Within Dose Groups, Placebo-controlled Phase I Trial in Healthy Japanese Male Volunteers to Investigate Safety, Tolerability and Pharmacokinetics of Different Doses of BI 655075 (Part 1) and to Explore the Effective Dose of BI 655075 to Reverse Dabigatran Anticoagulant… |
| Lead sponsor | Boehringer Ingelheim, Industry |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Healthy |
| Intervention type | Drug |
| Interventions | Placebo to dose, Idarucizumab, Placebo to Idarucizumab, dabigatran |
| Enrollment | 80 |
| Start date | Jan 1, 2014 |
| Primary completion | Aug 1, 2014 |
| Completion | Aug 1, 2014 |
| First posted | Jan 7, 2014 |
| Last update posted | Feb 11, 2016 |
| Countries | Japan |
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: