Multiple-Dose Study of VGX-1027 in Healthy Subjects

NCT ID: NCT00760396

Last Updated: 2009-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-04-30

Brief Summary

The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects administered for 5 days.

Detailed Description

This study will evaluate:

• The safety and tolerability of multiple oral doses of VGX 1027 in the range of 40 to 400mg.
• The pharmacokinetics of VGX 1027 in healthy subjects following the first oral dose (Day 1) and at steady state (Day 5).

Conditions

Healthy

Study Design

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

Study Groups

Group 1

40mg QD dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subjects will

Group 2

100mg QD dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subjects will

Group 3

200mg QD dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subjects will

Group 4

200mg BID dose group

Group Type: EXPERIMENTAL

VGX-1027

Intervention Type: DRUG

Subjects will

Interventions

VGX-1027

Subjects will

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must give written informed consent.
• Healty 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 (BMI) of 18 to 30kg/m2 ±0.5kg/m2 inclusive.

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 study participation and 3 months following dosing.
• Any significant acute or chronic medical illness
• Current or recent (within 3 months) 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 a 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 determination.
• 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 druge within 4 weeks prior to enrollment or greater than 4 weeks for investigational drugs that may have a longer half life.
• Use of any prescription drugs, 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 three 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

• 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, Inc.

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

CAT002

Identifier Type: -

Identifier Source: org_study_id