HealthyPhase 1NCT00760396
Multiple-Dose Study of VGX-1027 in Healthy Subjects
A Phase 1 study testing VGX-1027 in people with Healthy, run by VGX Pharmaceuticals, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VGX-1027
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
About this study
Official title: A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects
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.
Read the 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
- Being tested
- VGX-1027
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGX-1027Drug
Subjects will
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 40mg QD dose group Receives: Drug: VGX-1027 |
| Group 2 | Experimental | 100mg QD dose group Receives: Drug: VGX-1027 |
| Group 3 | Experimental | 200mg QD dose group Receives: Drug: VGX-1027 |
| Group 4 | Experimental | 200mg BID dose group Receives: Drug: VGX-1027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting.
Measured: Day 8
Secondary outcomes (1)
Pharmacokinetics
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VGX Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GeneOne Life Science, Inc.
- Investigators
- Stephan A Bart, MD, Principal investigator, SNBL Clinical Pharmacology Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760396
- Sponsor's protocol ID
- CAT002
- Status last verified
- Apr 2009
- First submitted
- 25 Sep 2008
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00760396
- Acronym / sponsor ID
- CAT002
- Conditions
- Healthy
- Keywords
- healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VGX Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- GeneOne Life Science, Inc.
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: VGX-102740mg QD dose group |
| Group 2 | Experimental | Drug: VGX-1027100mg QD dose group |
| Group 3 | Experimental | Drug: VGX-1027200mg QD dose group |
| Group 4 | Experimental | Drug: VGX-1027200mg BID dose group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VGX-1027Subjects will | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting.
Time frame: Day 8
1 secondary outcome
Pharmacokinetics
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan A Bart, MD principal investigator
SNBL Clinical Pharmacology Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VGX-1027 in people with Healthy, run by VGX Pharmaceuticals, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting. (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2009.