46
Participants
Start Date
August 31, 2013
Primary Completion Date
March 31, 2014
Study Completion Date
May 31, 2014
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."
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.
Placebo
GCC-4401C matching placebo(Capsule): Strength is not applicable. GCC-4401C and placebo will be administered double-blind after a 10 hours fast.
PAREXEL Internatonal, Early Phase Clinical Unit _Los Angeles
Lead Sponsor
Collaborators (1)
Parexel
INDUSTRY
Green Cross Corporation
INDUSTRY