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
Overview
- Phase
- Phase 1
- Intervention
- GCC-4401C
- Conditions
- Healthy Volunteers
- Sponsor
- Green Cross Corporation
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- The safety of GCC-4401C when repeatedly administered to healthy male adults
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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 -
- •Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -
Arms & Interventions
Rivaroxaban
Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease
Intervention: GCC-4401C
Placebo
GCC-4401C matching placebo capsule
Intervention: GCC-4401C
GCC-4401C
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.
Intervention: Rivaroxaban
GCC-4401C
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.
Intervention: Placebo
Outcomes
Primary Outcomes
The safety of GCC-4401C when repeatedly administered to healthy male adults
Time Frame: Up to 17 ~ 19 days after administration
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
Secondary Outcomes
- 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)