Multiple-Dose Study of VGX-1027 in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00760396

Run by

VGX Pharmaceuticals, LLC

People needed

40

Starts

2008-09-01

Expected to finish

2009-04-01

Last updated by the study team

2009-04-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• SNBL Clinical Pharmacology Center, Inc. — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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