HealthyPhase 1NCT00721461
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)
A Phase 1 study testing V930 in people with Healthy, run by Merck Sharp & Dohme LLC.
Trial summary
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V930
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Oct 2005
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be between the ages of 18 and 35
- Woman who are able to become pregnant must use an acceptable form of birth control
Who cannot join
- You are breast feeding
- You have taken any type of pain reliever within 12 hours of electrostimulation
- You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study
- You have muscle atrophy, weakness or neuromuscular disorder
About this study
Official title: Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.
- Conditions
- Healthy
- Being tested
- V930
- Keywords
- Assess, Tolerability, MedPulser DDS device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V930Biological
Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | V930 Receives: Biological: V930 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the tolerability of the MedPulser DDS device.
Measured: Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJul 2005
- Primary completionOct 2005
- Study completionOct 2005
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.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Inovio Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721461
- Sponsor's protocol ID
- V930-001
- Other IDs
- 2008_537
- Status last verified
- Aug 2015
- First submitted
- 22 Jul 2008
- Last updated
- 4 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age
- ClinicalTrials.gov ID
- NCT00721461
- Acronym / sponsor ID
- V930-001
- Conditions
- Healthy
- Keywords
- Assess, Tolerability, MedPulser DDS device
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Inovio Pharmaceuticals
- Study start
- Jul 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 24 Jul 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.
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: V930V930 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be between the ages of 18 and 35
- Woman who are able to become pregnant must use an acceptable form of birth control
Key exclusion criteria (4 listed)
- You are breast feeding
- You have taken any type of pain reliever within 12 hours of electrostimulation
- You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study
- You have muscle atrophy, weakness or neuromuscular disorder
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 |
|---|---|---|
| V930Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm. | Biological | 1 |
Primary outcome
Assess the tolerability of the MedPulser DDS device.
Time frame: Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation.
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 4 Aug 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V930 in people with Healthy, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 4 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Assess the tolerability of the MedPulser DDS device. (time frame: Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation.). 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 4 Aug 2015.