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

NCT01954238 | Completed Phase 1 DMC

• 1 other identifier: GC2107_102
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Anti-coagulant; Coagulation factor Xa inhibitor

Outcome Measures

Primary Outcomes (1)

• The safety of GCC-4401C when repeatedly administered to healthy male adults

  The following safety parameters will be recorded at regular intervals during the clinical study\_ * Vital signs (supine blood pressure (BP) and pulse, oral body temperature, respiratory rate (RR)) * Twelve-lead ECG * 24-hour telemetry * Clinical laboratory testing (hematology, clinical chemistry, coagulation and urinalysis) * Hemoccult test * Adverse event assessments * Concomitant medication assessments * Physical examinations

  Up to 17 ~ 19 days after administration

Secondary Outcomes (1)

• The Pharmacokinetics (PK) of GCC-4401C when repeatedly administered to healthy male adults

  Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose on Day 1 and Day 9 and at pre dose on Days 5 through 8

Other Outcomes (1)

• The Pharmacodynamics (PD) of GCC-4401C when repeatedly administered to healthy male adults

  predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose on Day 1 and Day 9

Study Arms (3)

Rivaroxaban

ACTIVE COMPARATOR

Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease

Drug: GCC-4401C

Placebo

PLACEBO COMPARATOR

GCC-4401C matching placebo capsule

Drug: GCC-4401C

GCC-4401C

EXPERIMENTAL

Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease. It is a novel molecule with a structural similarity to Rivaroxaban.

Drug: Rivaroxaban; Drug: Placebo

Interventions

GCC-4401C DRUG

* 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.

Also known as: Nokxaban

Placebo; Rivaroxaban

Rivaroxaban DRUG

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.

Also known as: Xarelto

GCC-4401C

Placebo DRUG

GCC-4401C matching placebo(Capsule): Strength is not applicable. GCC-4401C and placebo will be administered double-blind after a 10 hours fast.

Also known as: GCC-4401C matching placebo

GCC-4401C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject voluntarily has agreed to participate in this study and signed an Institutional Review Board (IRB)-approved informed consent before any of the Screening procedures will be performed.
• Males between 18 to 45 years of age, inclusive, at Screening.
• Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past month prior to screening) and by urine cotinine concentration (\< 400 ng/mL) at Screening.
• Body mass index (BMI) between 18.5 and 28.0 kg/m2 at Screening.
• Healthy, determined by pre-study medical evaluation and Investigator/designee discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).

You may not qualify if:

• Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
• Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Have any of the following, which may put them at increased risk with anticoagulant use: family history or personal history of bleeding disorders or diseases/syndromes that can either alter or increase the propensity for bleeding; any other contraindication to anticoagulant treatment, or increased bleeding risk, as judged by the Investigator.
• Are considering or scheduled to undergo any surgical procedure during the study.
• Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
• Fecal occult blood positive test at screening and admission.
• Subject has history of alcohol and/or illicit drug abuse within one year of the Screening visit.
• Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
• Positive alcohol breathalyzer test at Screening or Day -1.
• Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -1.
• Subject unwilling to avoid consumption of coffee and caffeine containing beverages within 48 hours prior to Day -1 until discharge from the clinical site.
• Subject unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Day -1 until discharge from the clinical site.
• Donation of blood (\> 500 mL) or blood products within 2 months (56 days) prior to Day -1.
• Use of over-the-counter (OTC) medications, prescription medications, or herbal remedies from 14 days or 5 time their half-lives whatever is more, prior to Day -1 and vitamin from 7 days prior to Day -1, until End-of-Study. By exception, acetaminophen 1000 mg per day is permitted.
• Use of any drugs that induce or inhibit cytochrome P450 or P-glycoprotein within 30 days prior to dosing.

Sponsors & Collaborators

• Green Cross Corporation: lead
• Parexel: collaborator

Study Sites (1)

PAREXEL Internatonal

Early Phase Clinical Unit _Los Angeles, California, CA 91206, United States

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Han, M.D.

  California Clinical Trials Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 1, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)