Expired Study
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Baltimore, Maryland 21201


Purpose:

To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.


Study summary:

This study will evaluate: - The safety and tolerability of a single dose of VGX-1027 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs). - The pharmacokinetic (PK) profile of VGX-1027 maximum concentration (Cmax)


Criteria:

Inclusion Criteria: - Must give written informed consent. - Healthy subjects as determined by no clinically significant deviation from normal as judged by the investigator in medical history, physical examination, ECGs and clinical laboratory evaluations - Body Mass Index of 18-30kg/m^2 inclusive - Males or females ages 18-60, inclusive. Women who are not of childbearing potential may enroll. Women must have a negative pregnancy test within 72 hours prior to start of study drug administration or be surgically sterile. Exclusion Criteria: - Women who are of childbearing potential - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or prior to study drug administration - Male subjects who are unwilling to agree to practice barrier contraception during the study and for three months following dosing - Any significant acute or chronic mental illness - Current or recent gastrointestinal disease that may impact the absorption of the drug - Any major surgery within 4 weeks of enrollment - Donation of blood or plasma to a blood bank or in a clinical study (except screening visit) within 4 weeks of enrollment - Blood transfusion within 4 weeks of enrollment - Inability to tolerate oral medication - Inability to be venipunctured and/or tolerate venous access - Recent (within 6 months) drug or alcohol abuse - History of bleeding disorder - History of head trauma or seizures - Any other sound medical, psychiatric and/or social reason as determined by the Investigator - Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, ECG, or clinical laboratory determinations - Positive urine screen for drugs of abuse - Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV 1/2 antibody - History of any significant drug allergy - Exposure to any investigational drug within 4 weeks prior to enrollment or greater that 4 weeks for investigational drugs that may have a longer half-life - Use of any prescription drugs or over the counter acid controllers within 4 weeks prior to enrollment - Use of any other drugs, including over the counter vitamins, medications and/or herbal preparations within 2 weeks prior to enrollment - Use of oral, injectable or implantable hormonal contraceptive agents within 3 months prior to enrollment - Use of alcohol containing beverages within 1 week prior to enrollment - Use of grapefruit containing products within 1 week prior to enrollment - Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious disease) illness must not be enrolled into this study.


NCT ID:

NCT00627120


Primary Contact:

Principal Investigator
Stephan A Bart, MD
SNBL Clinical Pharmacology Center Inc.


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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