Status:
COMPLETED
Comparative Effects of Aspirin and NHP-544C
Lead Sponsor:
Vanderbilt University
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The investigators will compare the effects of rapid release aspirin and NHP-544C on the prostacyclin response to intravenous bradykinin.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02189122
Start Date
July 1 2014
End Date
July 1 2015
Last Update
July 12 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232