MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects

NCT00513994 | Completed Phase 1

• 1 other identifier: 07-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.

Conditions

Healthy

Keywords

Pharmacokinetics; Nitroglycerin; pharmacokinetics study of nitroglycerin containing treatments

Outcome Measures

Primary Outcomes (1)

• The primary objective is the measurement and comparison of the levels of nitroglycerin and its 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.

  8 hours

Secondary Outcomes (1)

• A secondary objective is the observation of the volunteers for any adverse events

  2 weeks

Study Arms (1)

1

ACTIVE COMPARATOR

Drug: Nitroglycerin

Interventions

Nitroglycerin DRUG

MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP

Also known as: MQX-503, Nitro-Bid

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers 18 - 70 years of age.
• Subjects able to give written informed consent and comply with study requirements.
• Subjects willing and able to safely discontinue all current prescription therapies.
• Subjects who will agree not to participate in other clinical trials.
• Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.

You may not qualify if:

• Persons who would be put at risk by discontinuing prescription therapies.
• Subjects with a known allergy to nitroglycerin.
• Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.
• Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.
• Subjects who have participated in a study of an investigational drug within two weeks of visit 1.
• Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.
• Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1.
• Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.
• Pregnant or nursing women.
• Women of childbearing potential who are unwilling to comply with the contraceptive requirements.

Sponsors & Collaborators

• MediQuest Therapeutics: lead

Study Sites (1)

Charles River Clinical Services

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Adel Nada, M.D.

  Charles River Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 9, 2007
• Study Start: August 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 11, 2008

Record last verified: 2008-04

Locations

US (1)