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

PHASE1CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

March 31, 2014

Study Completion Date

May 31, 2014

Conditions
Healthy Volunteers
Interventions
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.

Trial Locations (1)

CA 91206

PAREXEL Internatonal, Early Phase Clinical Unit _Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Green Cross Corporation

INDUSTRY

NCT01954238 - A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers | Biotech Hunter | Biotech Hunter