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Baltimore, Maryland 21201


Purpose:

The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects administered for 5 days.


Study summary:

This study will evaluate: - The safety and tolerability of multiple oral doses of VGX 1027 in the range of 40 to 400mg. - The pharmacokinetics of VGX 1027 in healthy subjects following the first oral dose (Day 1) and at steady state (Day 5).


Criteria:

Inclusion Criteria: - Must give written informed consent. - Healty 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 (BMI) of 18 to 30kg/m2 ±0.5kg/m2 inclusive. 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 study participation and 3 months following dosing. - Any significant acute or chronic medical illness - Current or recent (within 3 months) 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 a 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 determination. - 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 druge within 4 weeks prior to enrollment or greater than 4 weeks for investigational drugs that may have a longer half life. - Use of any prescription drugs, 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 three 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


NCT ID:

NCT00760396


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: October 09, 2019

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