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

This study has been completed.
Sponsor:
Collaborator:
VGX International, 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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: VGX-1027
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects

Further study details as provided by VGX Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting. [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Day 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: February 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627120

Locations
United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VGX Pharmaceuticals, LLC
VGX International, Inc.
Investigators
Principal Investigator: Stephan A Bart, MD SNBL Clinical Pharmacology Center Inc.
  More Information

No publications provided

Responsible Party: C. Jo White, MD, VGX Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00627120     History of Changes
Other Study ID Numbers: CAT001
Study First Received: January 17, 2008
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by VGX Pharmaceuticals, LLC:
healthy volunteers

ClinicalTrials.gov processed this record on April 22, 2014