NCT01489774

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

A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dose, Dose-escalation Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 After Oral Administration in Healthy Male Subjects, Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Placebo	single and multiple dose
DRUG	CJ-12406	single and multiple dose

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2011-12-12
• Last updated: 2012-08-02

Locations

1 site across 1 country: South Korea