- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00513994
MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
April 8, 2008 updated by: MediQuest Therapeutics
MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects
The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98418
- Charles River Clinical Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers 18 - 70 years of age.
- Subjects able to give written informed consent and comply with study requirements.
- Subjects willing and able to safely discontinue all current prescription therapies.
- Subjects who will agree not to participate in other clinical trials.
- Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.
Exclusion Criteria:
- Persons who would be put at risk by discontinuing prescription therapies.
- Subjects with a known allergy to nitroglycerin.
- Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.
- Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.
- Subjects who have participated in a study of an investigational drug within two weeks of visit 1.
- Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.
- Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1.
- Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.
- Pregnant or nursing women.
- Women of childbearing potential who are unwilling to comply with the contraceptive requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
|
MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective is the measurement and comparison of the levels of nitroglycerin and its metabolites in the blood of healthy human volunteers after a single topical dose of MQX-503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
Time Frame: 8 hours
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A secondary objective is the observation of the volunteers for any adverse events
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adel Nada, M.D., Charles River Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
August 7, 2007
First Submitted That Met QC Criteria
August 8, 2007
First Posted (Estimate)
August 9, 2007
Study Record Updates
Last Update Posted (Estimate)
April 11, 2008
Last Update Submitted That Met QC Criteria
April 8, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Nitroglycerin
-
Assiut UniversityUnknown
-
University of Texas Southwestern Medical CenterUS Department of Veterans AffairsCompletedRectal CancerUnited States
-
MediQuest TherapeuticsCompletedRaynaud's PhenomenonUnited States
-
Maastricht Radiation OncologyAnticancer Fund, Belgium; Reliable Cancer TherapiesTerminatedNon Small Cell Lung Cancer (NSCLC)Netherlands
-
University of California, San FranciscoCompletedProlonged Second Stage of LaborUnited States
-
Thomas Jefferson UniversityNot yet recruitingArtery; Dilatation
-
Icahn School of Medicine at Mount SinaiWithdrawn
-
Deborah Heart and Lung CenterUnknownPeripheral Arterial Disease
-
Forest LaboratoriesWithdrawnAnal FissureUnited States
-
Tri-Service General HospitalCompleted