NCT01651234

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Male

Interventions

Type	Name	Description
DRUG	GCC-4401	* Swedish Orange opaque hard gelatin capsules of size 1 with no markings for oral use * single dose * dosage * Cohort 1: 2.5-mg GCC-4401C * Cohort 2: 5.0-mg GCC-4401C * Cohort 3: 10-mg GCC-4401C * Cohort 4: 20-mg GCC-4401C * Cohort 5: 40-mg GCC-4401C * Cohort 6: 80-mg GCC-4401C
DRUG	GCC-4401C	* Capsule, identical in appearance to GCC-4401C, for oral use * single dose * dosage * Cohort 1: 2.5-mg matching placebo * Cohort 2: 5.0-mg matching placebo * Cohort 3: 10-mg matching placebo * Cohort 4: 20-mg matching placebo * Cohort 5: 40-mg matching placebo * Cohort 6: 80-mg matching placebo

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-07-27
• Last updated: 2012-08-29

Locations

1 site across 1 country: United States