NCT01954238

A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers

A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Sequential Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GCC-4401C in Healthy Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.

Detailed description

The primary objective is to investigate the safety, tolerability, and pharmacokinetics of multiple doses of GCC-4401C in healthy male subjects. Forty-six subjects are planned for enrollment. The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort. In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion. Within each of the five cohorts, six subjects will be randomized to GCC-4401C and two subjects will be randomized to placebo. The secondary objectives of this study are * To characterize the single dose safety, tolerability, and PK after oral administration of GCC-4401C in healthy male subjects. * To characterize the multiple dose pharmacodynamics after oral administration of GCC-4401C in healthy male subjects. * To determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials. * To compare the PK and PD of GCC-4401C with an active rivaroxaban (Xarelto®)group at 20 mg in healthy male subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GCC-4401C	* Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease. * The dose selection for this clinical study was based on the safety, Pharmacokinetics and Pharmacodynamics results of the single dose study. * GCC-4401C was well tolerated in the single ascending dose study up to the highest single oral dose administered of 80 mg from 2.5 mg in 48 subjects. * The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort. * In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion.
DRUG	Rivaroxaban	Rivaroxaban (Xarelto®) 20 mg tablets for oral administration IMP, placebo and comparator will be administered the same time points. The comparator will be administered open-label 30 minutes after a standard breakfast.
DRUG	Placebo	GCC-4401C matching placebo(Capsule): Strength is not applicable. GCC-4401C and placebo will be administered double-blind after a 10 hours fast.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-03-01
• Completion: 2014-05-01
• First posted: 2013-10-01
• Last updated: 2014-12-23

Locations

1 site across 1 country: United States