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

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ClinicalTrials.gov Identifier: NCT00721461
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : August 4, 2015
Sponsor:
Collaborators:
University of California, San Diego
Inovio Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.

Condition or disease Intervention/treatment Phase
Healthy Biological: V930 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : July 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Arm Intervention/treatment
Experimental: 1
V930
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.



Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721461


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
University of California, San Diego
Inovio Pharmaceuticals
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00721461     History of Changes
Other Study ID Numbers: V930-001
2008_537
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Assess
Tolerability
MedPulser DDS device