NCT01925521

OPS-2071 Single and Multiple Dose Study to Investigate PK and PD Profile in Healthy Korean Male Subjects.

A phase1,Randomized,Double-blind,Placebo-controlled,Two-part,Sequential Ascending Single and Multiple Dose Study to Investigate the Safety, Tolerability and the PK and PD Profile of OPS-2071 in Healthy Male Korean Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Part1 : OPS-2071	single oral dose under fasted condition
DRUG	Part1 : Placebo of OPS-2071	single oral dose under fasted condition
DRUG	Part2 : OPS-2071	multiple twice-daily oral dosing for 5-7days
DRUG	Part2 : Placebo of OPS-2071	multiple twice-daily oral dosing for 5-7days

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-08-19
• Last updated: 2014-11-07

Locations

1 site across 1 country: South Korea