- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651234
A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers
August 27, 2012 updated by: Green Cross Corporation
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC-4401C in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD f\profile.
Study Overview
Detailed Description
The primary objective of this study is to investigate the safety and tolerability following administration of single ascending doses of GCC4401C in healthy male subjects; and the secondary objective of this study is to characterize the single-dose PK profile after oral administration of GCC-4401C, and to determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Quintiles Phase1 Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
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;
- Positive urine drug screen or urine alcohol screen at medical screening or check-in;
- History of alcohol, drug, or substance abuse, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition in the past 12 months;
- Positive test result for fecal occult blood, measured at screening and/or at check-in to the clinic;
- Consumption of alcohol within 48 hours prior to dosing;
- Intake of more than 14 units (a unit is 12 oz beer, 5 oz wine, or 1.5 oz liquor) of alcohol per week;
- Use of any drugs that induce or inhibit cytochrome P450 or P-glycoprotein within 30 days prior to dosing;
- Use of any prescribed or over-the-counter (OTC) medications including antacids, analgesics, herbal remedies, vitamins, and minerals (with the exception of up to 3 grams of acetaminophen) or medications containing aspirin or nonsteroidal anti-inflammatory medications with anticoagulant effects within 2 weeks prior to dosing;
- Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of dosing;
- Planning to father a child or donate sperm during the study and 3 months following dosing;
- Do not have veins suitable for cannulation or multiple venipunctures;
- Have previously participated in this study;
- Donation of plasma or blood products within 1 month of screening or any blood donation/blood loss greater than 450 mL during the 3 months prior to screening; or
- Any other factor that the Investigator thinks will increase subject risk with participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
|
EXPERIMENTAL: Active
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number and percentage of subjects experiencing 1 or more AEs will be summarized by treatment/dose group, relationship to study drug, and severity.
Time Frame: up to 7 ~ 10 days after administraion
|
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.
Time Frame: up to 7 ~10 days after administration
|
up to 7 ~10 days after administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the single-dose pharmacokinetic behavior
Time Frame: 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
|
to characterize the single-dose pharmacokinetic behavior after oral administration of GCC-4401C
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the single-dose pharmacodynamics behavior
Time Frame: 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
|
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
August 1, 2012
Study Completion (ACTUAL)
August 1, 2012
Study Registration Dates
First Submitted
July 17, 2012
First Submitted That Met QC Criteria
July 26, 2012
First Posted (ESTIMATE)
July 27, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 29, 2012
Last Update Submitted That Met QC Criteria
August 27, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- GCC4401C-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Male
-
NGM Biopharmaceuticals, IncCompletedHealthy MaleUnited States
-
Samyang Biopharmaceuticals CorporationSeoul National University HospitalCompletedHealthy, MaleKorea, Republic of
-
Samyang Biopharmaceuticals CorporationChungnam National University HospitalCompleted
-
Hyundai Pharmaceutical Co., LTD.Completed
-
Hadassah Medical OrganizationActive, not recruitingPregnant, Healthy Females | Healthy Male NewbornsIsrael
-
BeiGeneCompletedHealthy | MaleUnited States
-
InventisBio Co., LtdActive, not recruiting
-
Idience Co., Ltd.Completed
-
3D Medicines (Sichuan) Co., Ltd.Recruiting
-
Eli Lilly and CompanyCompleted
Clinical Trials on GCC-4401
-
Cairo UniversityCompleted
-
The Affiliated Hospital of Qingdao UniversityRecruiting
-
Green Cross CorporationParexelCompleted
-
Inonu UniversityCompletedGLAUCOMA 1, OPEN ANGLE, D (Disorder)Turkey
-
Assiut UniversityCompletedPseudoexfoliation Syndrome | Pseudoexfoliation Glaucoma in Both Eyes | Pseudoexfoliation of Lens; GlaucomaEgypt
-
Green Cross CorporationAtlantic Research GroupRecruitingPrimary Immune DeficiencyUnited States