A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers

NCT01651234 | Completed Phase 1

• 1 other identifier: GCC4401C-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD f\\profile.

Conditions

Healthy Male

Outcome Measures

Primary Outcomes (2)

• The number and percentage of subjects experiencing 1 or more AEs will be summarized by treatment/dose group, relationship to study drug, and severity.

  up to 7 ~ 10 days after administraion

• Statistics for clinical laboratory data(continuous variables only), vital signs, and ECF intervals will be presented for each evaluation during the study and for change from baseline to postdose evaluations.

  up to 7 ~10 days after administration

Secondary Outcomes (1)

• the single-dose pharmacokinetic behavior

  at predose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, and 48 hours postdose

Other Outcomes (1)

• the single-dose pharmacodynamics behavior

  at predose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, and 48 hours postdose

Study Arms (2)

Active

EXPERIMENTAL

Drug: GCC-4401

Placebo

PLACEBO COMPARATOR

Drug: GCC-4401C

Interventions

GCC-4401 DRUG

* Swedish Orange opaque hard gelatin capsules of size 1 with no markings for oral use * single dose * dosage * Cohort 1: 2.5-mg GCC-4401C * Cohort 2: 5.0-mg GCC-4401C * Cohort 3: 10-mg GCC-4401C * Cohort 4: 20-mg GCC-4401C * Cohort 5: 40-mg GCC-4401C * Cohort 6: 80-mg GCC-4401C

Active

GCC-4401C DRUG

* Capsule, identical in appearance to GCC-4401C, for oral use * single dose * dosage * Cohort 1: 2.5-mg matching placebo * Cohort 2: 5.0-mg matching placebo * Cohort 3: 10-mg matching placebo * Cohort 4: 20-mg matching placebo * Cohort 5: 40-mg matching placebo * Cohort 6: 80-mg matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);
• Normal healthy males between 18 and 55 years of age, inclusive, at the time of consent;
• A body mass index (BMI) of at least 18.5 kg/m2 but no more than 30 kg/m2 (BMI is defined as the subject's weight in kilograms divided by the square root of the subject's height in meters);
• In general good health based on screening medical history, physical examination (defined as the absence of any clinically significant abnormalities), vital signs, and clinical laboratory values (hematology, serum chemistry, and urinalysis);
• Have a normal ECG (defined as Fridericia's correction for QT interval \[QTcF\] less than or equal to 450 ms) at screening, Day -1 and Day 1, predose (baseline). Repeat ECG measurements will be allowed at the baseline assessment for QTcF values above 450 ms and the average will be used to assess eligibility.
• Male subjects must use barrier contraception during sexual intercourse, ie, condoms, from the first day of dosing until 3 months after the last dosing with GCC-4401C; and
• Nonsmokers (defined as not having smoked or used any nicotine containing products for at least 1 month, and having a urine cotinine less than 400 ng/mL).

You may not qualify if:

• Subjects presenting with any of the following will not be entered into the study:
• Have clinically significant abnormal history, physical findings, or laboratory values at the prestudy screening assessment that could interfere with the objectives of the study or the safety of the subjects;
• 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;
• severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within the past 3 months;
• endoscopic peptic-ulcer disease within the past 3 years or clinically significant gastrointestinal, genitourinary, or gum bleeding within the past 3 months;
• a personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage; or rectal bleeding within 3 months prior to screening;
• any history of thrombotic or hemorrhagic stroke;
• clinically significant laboratory abnormalities (hemoglobin less than 12.0 g/dL, prolonged PT or INR, prolonged aPTT, elevated liver enzymes, elevated serum creatinine or blood urea nitrogen (BUN) which is considered clinically significant by the Investigator, or platelet count less than 150,000/mm3 or greater than 600,000/mm3). Mildly elevated BUN with normal serum creatinine values which are determined not to be clinical significant by the Investigator are permitted. These significant laboratory values may be repeated for confirmation; or
• any other contraindication to anticoagulant treatment, or increased bleeding risk, as judged by the Investigator.
• Have known positive test for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) 1, or HIV 2;
• Are considering or scheduled to undergo any surgical procedure during the study;
• Have received an investigational product within 30 days prior to dosing;
• Presence or history of severe adverse reaction to any drug;
• Involvement in the planning and/or conduct of the study;

Sponsors & Collaborators

• Green Cross Corporation: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Quintiles Phase1 Unit

Overland Park, Kansas, 66211, United States

Location

Study Design

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

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 27, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 29, 2012

Record last verified: 2012-08

Locations

US (1)