Multiple-Dose Study of VGX-1027 in Healthy Subjects

A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: VGX-1027

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 dose (Day 1) and at steady state (Day 5).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • SNBL Clinical Pharmacology Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 40mg QD dose group	Drug: VGX-1027; Subjects will
Experimental: Group 2; 100mg QD dose group	Drug: VGX-1027; Subjects will
Experimental: Group 3; 200mg QD dose group	Drug: VGX-1027; Subjects will
Experimental: Group 4; 200mg BID dose group	Drug: VGX-1027; Subjects will

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting.	Day 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	Day 8

Collaborators and Investigators

• Sponsor: VGX Pharmaceuticals, LLC
• Collaborators: GeneOne Life Science, Inc.
• Investigators: Principal Investigator: Stephan A Bart, MD, SNBL Clinical Pharmacology Center, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (Estimate): September 26, 2008

Study Record Updates

• Last Update Posted (Estimate): April 7, 2009
• Last Update Submitted That Met QC Criteria: April 6, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: healthy volunteers
• Other Study ID Numbers: CAT002