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

This study has been completed.
Sponsor:
Collaborator:
GeneOne Life Science, Inc.
Information provided by:
VGX Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00627120
First received: January 17, 2008
Last updated: January 8, 2009
Last verified: January 2009

January 17, 2008
January 8, 2009
February 2008
September 2008   (final data collection date for primary outcome measure)
Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting. [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00627120 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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)
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
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: 1
    1mg dose group
    Intervention: Drug: VGX-1027
  • Experimental: 2
    10mg dose group
    Intervention: Drug: VGX-1027
  • Experimental: 3
    100mg dose group
    Intervention: Drug: VGX-1027
  • Experimental: 4
    200mg dose group
    Intervention: Drug: VGX-1027
  • Experimental: 5
    400mg dose group
    Intervention: Drug: VGX-1027
  • Experimental: 6
    800mg dose group
    Intervention: Drug: VGX-1027
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00627120
CAT001
No
C. Jo White, MD, VGX Pharmaceuticals, Inc
VGX Pharmaceuticals, LLC
GeneOne Life Science, Inc.
Principal Investigator: Stephan A Bart, MD SNBL Clinical Pharmacology Center Inc.
VGX Pharmaceuticals, LLC
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP