Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
- Registration Number
- NCT00627120
- Lead Sponsor
- VGX Pharmaceuticals, LLC
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 VGX-1027 1mg dose group 2 VGX-1027 10mg dose group 3 VGX-1027 100mg dose group 4 VGX-1027 200mg dose group 5 VGX-1027 400mg dose group 6 VGX-1027 800mg dose group
- Primary Outcome Measures
Name Time Method Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting. Day 8
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Day 4
Trial Locations
- Locations (1)
SNBL Clinical Pharmacology Center
🇺🇸Baltimore, Maryland, United States