drugset / Trial / NCT03510663
Phase I Study of OPC-61815
RandomizedCrossoverTriple-blindTreatment
Summary
To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects
Timeline
- Start
- 2018-05-08
- Primary completion
- 2018-07-05
- Completion
- 2018-07-05
Outcome
Met primary endpoint
registry analysis (superiority test); OPC-61815 16 mg vs Placebo; Least Squares Mean Difference 2.7 (90% CI 0.4 to 4.9) NCT03510663 ↗
registry analysis (superiority test); OPC-61815 32 mg vs Placebo; Least Squares Mean Difference 2.0 (90% CI -0.2 to 4.2) NCT03510663 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moxifloxacin | Small molecule | 400 mg | — |
| Subject | OPC-61815 | Unknown | 16 mg | Intravenous |
| Subject | OPC-61815 | Unknown | 32 mg | Intravenous |