Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects

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

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

Study Overview

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

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 1mg dose group	Drug: VGX-1027; Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
Experimental: 2; 10mg dose group	Drug: VGX-1027; Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
Experimental: 3; 100mg dose group	Drug: VGX-1027; Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
Experimental: 4; 200mg dose group	Drug: VGX-1027; Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
Experimental: 5; 400mg dose group	Drug: VGX-1027; Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
Experimental: 6; 800mg dose group	Drug: VGX-1027; Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	Day 4

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: February 1, 2008
• Primary Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: January 17, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimate): February 29, 2008

Study Record Updates

• Last Update Posted (Estimate): January 9, 2009
• Last Update Submitted That Met QC Criteria: January 8, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: healthy volunteers
• Other Study ID Numbers: CAT001