- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189122
Comparative Effects of Aspirin and NHP-544C
June 3, 2016 updated by: Nancy J. Brown, Vanderbilt University
Comparative Effects of Rapid-Release Aspirin and NHP-544C on Basal and Bradykinin Stimulated Prostacyclin Production
The investigators will compare the effects of rapid release aspirin and NHP-544C on the prostacyclin response to intravenous bradykinin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group 1:Aspirin/placebo
Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days.
Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
|
Bradykinin will be given intravenously in graded doses.
Each dose will be given for 15 minutes.
Other Names:
Subjects will take Aspirin 81 mg per day for five days.
Other Names:
Subjects will take aspirin 162 mg per day for 5 days.
Other Names:
Subjects will take matching placebo for five days.
|
ACTIVE_COMPARATOR: Group 2:NHP-544C/placebo
Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days.
Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
|
Bradykinin will be given intravenously in graded doses.
Each dose will be given for 15 minutes.
Other Names:
Subjects will take matching placebo for five days.
Subjects will take NHP544C 81 mg per day for five days.
Subjects will take NHP544C 162 mg once a day for five days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose
Time Frame: 24 hour collection
|
24 hour collection
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Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose
Time Frame: 24 hour collection
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24 hour collection
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Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose
Time Frame: 24 hour collection
|
24 hour collection
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Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose
Time Frame: 24 hour collection
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24 hour collection
|
Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose
Time Frame: 24 hour collection
|
24 hour collection
|
Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose
Time Frame: 24 hour collection
|
24 hour collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
July 1, 2015
Study Registration Dates
First Submitted
July 10, 2014
First Submitted That Met QC Criteria
July 11, 2014
First Posted (ESTIMATE)
July 14, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 12, 2016
Last Update Submitted That Met QC Criteria
June 3, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Protease Inhibitors
- Cysteine Proteinase Inhibitors
- Aspirin
- Bradykinin
- Kininogens
Other Study ID Numbers
- 140707
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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