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

This study has been completed.
Sponsor:
Collaborators:
University of California, San Diego
Inovio Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00721461
First received: July 22, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Healthy
Biological: V930
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721461

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00721461     History of Changes
Other Study ID Numbers: V930-001, 2008_537
Study First Received: July 22, 2008
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014