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

Raynaud's Phenomenon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841594
• Other study ID #: 08-001
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2009
• Last updated: May 13, 2011
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: May 2011
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud's Phenomenon

Intervention

Drug:
• nitroglycerin 0.9 % (MXQ-503)
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
• Nitroglycerin ointment 2%, USP
MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Locations

Country	Name	City	State
United States	Charles River Clinical Services	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Observation for any adverse events such as headache.		3 weeks	Yes