drugset / Trial / NCT04182958
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
NaSingle-groupOpen-labelTreatment
Summary
* To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. * To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 * To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815 * To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815
Timeline
- Start
- 2019-11-25
- Primary completion
- 2019-12-19
- Completion
- 2019-12-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OPC-61815 | Unknown | — | Intravenous |
Indications
No indication recorded.