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

NCT ID: NCT00627120

Last Updated: 2009-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29

Brief Summary

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

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)

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

1mg dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

2

10mg dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

3

100mg dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

4

200mg dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

5

400mg dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

6

800mg dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GeneOne Life Science, Inc.

INDUSTRY

Sponsor Role: collaborator

VGX Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

VGX Pharmaceuticals, Inc

Principal Investigators

Stephan A Bart, MD

Role: PRINCIPAL_INVESTIGATOR

SNBL Clinical Pharmacology Center, Inc.

Locations

SNBL Clinical Pharmacology Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

CAT001

Identifier Type: -

Identifier Source: org_study_id