Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954238
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2013-09-23
Brief Title:
A Study to Access Safety Tolerability PharmacokineticsPK and PharmacodynamicsPD of Orally Administered GCC-4401C in Healthy Volunteers
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
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
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety tolerability and PharmacokineticsPharmacodynamics 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 Xareltogroup at 20 mg 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 Xareltogroup at 20 mg in healthy male subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None