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

MediQuest Therapeutics

Status and phase: Completed; Phase 1

Conditions: Raynaud's Phenomenon

Treatments: Drug: Nitroglycerin ointment 2%, USP; Drug: nitroglycerin 0.9 % (MXQ-503)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841594

08-001

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

1

Active Comparator group

Description:

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the hand.

Treatment:

Drug: nitroglycerin 0.9 % (MXQ-503)

2

Active Comparator group

Description:

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP. Applied to the chest.

Treatment:

Drug: Nitroglycerin ointment 2%, USP