We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721461
First Posted: July 24, 2008
Last Update Posted: August 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of California, San Diego
Inovio Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
July 22, 2008
July 24, 2008
August 4, 2015
July 2005
October 2005   (Final data collection date for 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. ]
Same as current
Complete list of historical versions of study NCT00721461 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Healthy
Biological: V930
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.
Experimental: 1
V930
Intervention: Biological: V930
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2005
October 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be between the ages of 18 and 35
  • Woman who are able to become pregnant must use an acceptable form of birth control

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00721461
V930-001
2008_537
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
  • University of California, San Diego
  • Inovio Pharmaceuticals
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP