MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison

Study Overview
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Brief Summary
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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.

Official Title
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MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects

Conditions
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Raynaud's Phenomenon

Intervention / Treatment
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* Drug: nitroglycerin 0.9 % (MXQ-503)
* Drug: Nitroglycerin ointment 2%, USP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the hand. | Drug: nitroglycerin 0.9 % (MXQ-503)<br>* MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.<br>|
| Active Comparator: 2<br>MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the chest. | Drug: Nitroglycerin ointment 2%, USP<br>* MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation for any adverse events such as headache. |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers