Status:
COMPLETED
Multiple-Dose Study of VGX-1027 in Healthy Subjects
Lead Sponsor:
VGX Pharmaceuticals, LLC
Collaborating Sponsors:
GeneOne Life Science, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00760396
Start Date
September 1 2008
End Date
April 1 2009
Last Update
April 7 2009
Active Locations (1)
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1
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States, 21201