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

NCT01925521 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-11-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Korea Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • InJin Jang, M.D.,Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01925521 on ClinicalTrials.gov