Clinical trial NCT00760396: Multiple-Dose Study of VGX-1027 in Healthy Subjects
Official title: A Placebo-Controlled, Ascending Multiple-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: 2008-09-26
Enrollment: 40
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: 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).

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

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