Back to resultsMQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
Primary Purpose
Raynaud's Phenomenon
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
nitroglycerin 0.9 % (MXQ-503)
Nitroglycerin ointment 2%, USP
Sponsored by
About this trial
This is an interventional treatment trial for Raynaud's Phenomenon focused on measuring healthy volunteers
Eligibility Criteria
Inclusion Criteria:
- 18 to 50 years of age
- Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
- Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.
Exclusion Criteria:
- Subjects who can not safely discontinue current prescription medications.
- Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
- Subjects with an unstable medical problem.
- Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
- Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
- Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
- Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
- Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
- Pregnant or nursing women.
- Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.
Sites / Locations
- Charles River Clinical Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the hand.
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the chest.
Outcomes
Primary Outcome Measures
Measurement and comparison of the levels of nitroglycerin and its dinitrate 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.
Secondary Outcome Measures
Observation for any adverse events such as headache.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00841594
Brief Title
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
Official Title
MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MediQuest Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Phenomenon
Keywords
healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Applied to the hand.
Arm Title
2
Arm Type
Active Comparator
Arm Description
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Applied to the chest.
Intervention Type
Drug
Intervention Name(s)
nitroglycerin 0.9 % (MXQ-503)
Intervention Description
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin ointment 2%, USP
Intervention Description
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Primary Outcome Measure Information:
Title
Measurement and comparison of the levels of nitroglycerin and its dinitrate 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
12 hours
Secondary Outcome Measure Information:
Title
Observation for any adverse events such as headache.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 50 years of age
Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.
Exclusion Criteria:
Subjects who can not safely discontinue current prescription medications.
Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
Subjects with an unstable medical problem.
Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
Pregnant or nursing women.
Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.
Facility Information:
Facility Name
Charles River Clinical Services
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
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