Comparative Effects of Aspirin and NHP-544C
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Bradykinin (Drug); Aspirin 81 mg (Drug); Aspirin 162 mg (Drug); NHP544-C 81 mg (Drug); NHP544C 162 mg (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Nancy J Brown, MD, Principal Investigator, Affiliation: Vanderbilt University
Summary
The investigators will compare the effects of rapid release aspirin and NHP-544C on the
prostacyclin response to intravenous bradykinin.
Clinical Details
Official title: Comparative Effects of Rapid-Release Aspirin and NHP-544C on Basal and Bradykinin Stimulated Prostacyclin Production
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Urine thromboxane levelsUrine prostacyclin concentrations
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Ages of 18 and 55 years, inclusive
2. No significant medical issues without significant abnormal findings at the baseline
physical examination
3. Body mass index (BMI) between 18. 0 and 30. 0kg/m2 (weight (kg)/[height(m)]2)
4. 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
5. Ability to understand the requirements of the study and a willingness to comply with
all study procedures
Exclusion Criteria:
1. 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
2. Participation in an investigational drug study within the 30 days prior to CRC
admission
3. 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
4. History of metabolic, renal, hepatic, hemorrhagic stroke, gastrointestinal bleed,
cardiovascular disease, central nervous system disorder, or peptic ulcer disease or
other chronic bleeding disorder
5. History of gastrointestinal disorder that could result in incomplete absorption of
the study drug
6. Malignancy, or neurologic or psychiatric disorder
7. Abnormal laboratory value(s) determined to be clinically significant (in the opinion
of the Investigator)
8. History of illicit drug abuse in the past year or current evidence of such abuse in
the opinion of the investigator
9. Pregnancy or lactation
10. Acute illness within 1 week of CRC admission
11. Significant loss of blood or blood or plasma donation within 30 days of drug
administration
12. Hypersensitivity or allergy to NSAIDs, aspirin, ethylcellulose, polyvidone, castor
oil, magnesium stearate, tartaric acid, colloidal anhydrous silica, talc, gelatin,
titanium dioxide, erythrosine, or indigotin
13. History of aspirin resistance
14. 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
15. Alcohol consumption within 3 days of Day 1
16. Difficulty swallowing oral medications
17. Consumption of coffee or caffeine-containing beverages exceeding the equivalent of
five 8-oz cups of coffee per day on average
Locations and Contacts
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
Additional Information
Starting date: July 2014
Last updated: August 17, 2015
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