A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers

Healthy Male Clinical Trial

Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC-4401C in Healthy Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD f\profile.

Clinical Trial Description

The primary objective of this study is to investigate the safety and tolerability following administration of single ascending doses of GCC4401C in healthy male subjects; and the secondary objective of this study is to characterize the single-dose PK profile after oral administration of GCC-4401C, and to determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Healthy Male

Clinical Trial Details

NCT number	NCT01651234
Study type	Interventional
Source	Green Cross Corporation
Contact
Status	Completed
Phase	Phase 1
Start date	March 2012
Completion date	August 2012

View Details

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