Clinical trial NCT00627120: Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
Official title: A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: VGX Pharmaceuticals, LLC
Sponsor class: INDUSTRY
Collaborators: name: GeneOne Life Science, Inc.
First posted: 2008-02-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting.
timeFrame: Day 8
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Day 4
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
Study officials:
affiliation: SNBL Clinical Pharmacology Center, Inc.
name: Stephan A Bart, MD
role: PRINCIPAL_INVESTIGATOR
References: