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Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects

NCT01489774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2012-08-02

No results posted yet for this study

Summary

Study objectives

* To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CJ-12406 in healthy male subjects.
* To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to healthy male subjects.
* To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406 in healthy male subjects.

Conditions

  • Digestive System Diseases

Interventions

DRUG

Placebo

single and multiple dose

DRUG

CJ-12406

single and multiple dose

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Jae-Gook Shin, MD. PhD · Inje University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-04-30
Completion
2012-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01489774 on ClinicalTrials.gov