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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
GeneOne Life Science, 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 October 21, 2014