Multiple-Dose Study of VGX-1027 in Healthy Subjects
This study has been completed.
Sponsor:
VGX Pharmaceuticals, LLC
Collaborator:
VGX International, Inc.
Information provided by:
VGX Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00760396
First received: September 25, 2008
Last updated: April 6, 2009
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: VGX-1027 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects |
Further study details as provided by VGX Pharmaceuticals, LLC:
Primary Outcome Measures:
- Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting. [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
40mg QD dose group
|
Drug: VGX-1027
Subjects will
|
|
Experimental: Group 2
100mg QD dose group
|
Drug: VGX-1027
Subjects will
|
|
Experimental: Group 3
200mg QD dose group
|
Drug: VGX-1027
Subjects will
|
|
Experimental: Group 4
200mg BID dose group
|
Drug: VGX-1027
Subjects will
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760396
Locations
| United States, Maryland | |
| SNBL Clinical Pharmacology Center, Inc. | |
| Baltimore, Maryland, United States, 21201 | |
Sponsors and Collaborators
VGX Pharmaceuticals, LLC
VGX International, Inc.
Investigators
| Principal Investigator: | Stephan A Bart, MD | SNBL Clinical Pharmacology Center Inc. |
More Information
No publications provided
| Responsible Party: | C. Jo White, MD, VGX Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00760396 History of Changes |
| Other Study ID Numbers: | CAT002 |
| Study First Received: | September 25, 2008 |
| Last Updated: | April 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by VGX Pharmaceuticals, LLC:
|
healthy volunteers |
ClinicalTrials.gov processed this record on May 16, 2013