Comparative Effects of Aspirin and NHP-544C

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

The investigators will compare the effects of rapid release aspirin and NHP-544C on the prostacyclin response to intravenous bradykinin.

Key facts

Study ID

NCT02189122

Run by

Vanderbilt University

People needed

61

Starts

2014-07-01

Expected to finish

2015-07-01

Last updated by the study team

2016-07-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages of 18 and 55 years, inclusive
• No significant medical issues without significant abnormal findings at the baseline physical examination
• Body mass index (BMI) between 18.0 and 30.0kg/m2 (weight (kg)/[height(m)]2)
• For women - negative pregnancy test on Period 1, Day -1, or surgically sterilized, or is at least two years post-menopausal prior to randomization. Females of childbearing potential must be practicing an acceptable method of birth control to be eligible. Acceptable forms of birth control include: condom plus spermicide or condom plus other form of birth control including hormonal method (IUD, patch, ring, implant, or injectable), sterilization of partner, or non-hormonal IUD. The use of oral contraceptives is allowed during the study, but the subject must be on a stable dose for 30 days prior to the trial and throughout all four dosing periods
• Ability to understand the requirements of the study and a willingness to comply with all study procedures

You may not qualify if…

• Clinically significant and relevant medical history (including failure of a major organ system) or current medical illness, and is deemed by the Principal Investigator to be unsuitable to participate in the study
• Participation in an investigational drug study within the 30 days prior to CRC admission
• Use of aspirin or other NSAID within 14 days of Day 1 of the study. All other medications, prescription (with the exception of contraceptives), over-the-counter (OTC), herbal, and vitamin supplements must be discontinued 7 days prior to Day 1. If subjects are taking prescription medication, or OTC medication at the direction of a health care provider, that provider must confirm that it is acceptable for them to stop dosing for the duration of the study
• History of metabolic, renal, hepatic, hemorrhagic stroke, gastrointestinal bleed, cardiovascular disease, central nervous system disorder, or peptic ulcer disease or other chronic bleeding disorder
• History of gastrointestinal disorder that could result in incomplete absorption of the study drug
• Malignancy, or neurologic or psychiatric disorder
• Abnormal laboratory value(s) determined to be clinically significant (in the opinion of the Investigator)
• History of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the investigator
• Pregnancy or lactation
• Acute illness within 1 week of CRC admission
• Significant loss of blood or blood or plasma donation within 30 days of drug administration
• Hypersensitivity or allergy to NSAIDs, aspirin, ethylcellulose, polyvidone, castor oil, magnesium stearate, tartaric acid, colloidal anhydrous silica, talc, gelatin, titanium dioxide, erythrosine, or indigotin
• History of aspirin resistance
• History of alcohol abuse within past year. Current alcohol use should not exceed 14 standard alcoholic drinks per week. A drink is defined as 1.5 ounces (oz.) liquor, 12 oz. beer, or 6 oz. wine
• Alcohol consumption within 3 days of Day 1
• Difficulty swallowing oral medications
• Consumption of coffee or caffeine-containing beverages exceeding the equivalent of five 8-oz cups of coffee per day on average

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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