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

NCT00841594 | Completed Phase 1

• 1 other identifier: 08-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Raynaud's Phenomenon

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Observation for any adverse events such as headache.

  3 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: nitroglycerin 0.9 % (MXQ-503)

2

ACTIVE COMPARATOR

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

Drug: Nitroglycerin ointment 2%, USP

Interventions

nitroglycerin 0.9 % (MXQ-503) DRUG

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

1

Nitroglycerin ointment 2%, USP DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MediQuest Therapeutics: lead

Study Sites (1)

Charles River Clinical Services

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Raynaud Disease

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 11, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

US (1)