drugset / Trial / NCT01925521
OPS-2071 Single and Multiple Dose Study to Investigate PK and PD Profile in Healthy Korean Male Subjects.
Phase 1
Completed
96 enrolled
Korea Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
The objective of this trial is to evaluate the safety and tolerability of single and multiple ascending oral doses of OPS-2071 in healthy male Korean
Timeline
- Start
- 2013-08
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OPS-2071 | Small molecule | 30 mg | Oral |
| Subject | OPS-2071 | Small molecule | 60 mg | Oral |
| Subject | OPS-2071 | Small molecule | 120 mg | Oral |
| Subject | OPS-2071 | Small molecule | 240 mg | Oral |
| Subject | OPS-2071 | Small molecule | 300 mg | Oral |
| Subject | OPS-2071 | Small molecule | 600 mg | Oral |
| Subject | OPS-2071 | Small molecule | 900 mg | Oral |
| Subject | OPS-2071 | Small molecule | 1200 mg | Oral |
Indications
No indication recorded.