We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lipidomics Screening of Anti-inflammatory Drugs and Drug Candidates in Vitro - Part A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02095288
Recruitment Status : Active, not recruiting
First Posted : March 24, 2014
Last Update Posted : August 17, 2022
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

Cardiovascular complications of NSAIDs, selective for inhibition of COX-2, stimulated interest in microsomal prostaglandin E synthase-1 (mPGES-1) as an alternative drug target. Global deletion of mPGES-1 in mice suppresses PGE2 and augments PGI2 by PGH2 substrate rediversion. Unlike COX-2 inhibition or gene deletion, mPGES-1 deletion does not cause a predisposition to thrombogenesis and hypertension. However, cell-specific deletion of mPGES-1 reveals that the predominant substrate rediversion product amongst the prostaglandins varies by cell type, complicating drug development. We have developed an ultra performance liquid chromatography/ tandem mass spectrometry (UPLC-MS/MS) technique that allows the quantification of a wide range of lipids beyond the prostaglandin pathway (leukotrienes, anandamide and the 2-arachidonylglycerol cascades).

This study is designed to examine different pathway interventions from the arachidonic acid cascade by anti-inflammatory compounds (with a focus on mPGES-1 inhibition) in whole human blood in vitro (Part A) and ex vivo (Part B). In Part A, whole human blood will be donated by healthy volunteers and treated with screening compounds in vitro (outside of the body). Experiments will be performed to measure an array of lipids in plasma and serum from pre-stimulated whole blood treated with a single or a combination of the test compounds.

This study may reveal pathways previously unknown to be affected by the existing anti-inflammatory drugs and drug candidates, and will possibly suggest new indications and/or side effects.


Condition or disease Intervention/treatment
Healthy Procedure: Blood draw

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Broad-spectrum Lipidomics Screening of Anti-inflammatory Drugs and Drug Candidates in In Vitro Human Whole-blood Assay (hWBA)
Study Start Date : November 2013
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Group/Cohort Intervention/treatment
Healthy volunteers
Blood draw
Procedure: Blood draw
This is a single blood donation, no drugs or devices administered
Other Name: It's a single blood draw of 104 ml in total




Primary Outcome Measures :
  1. Quantification of lipids in plasma and serum from the whole blood treated with the test compounds [ Time Frame: Within a week after the blood draw ]

Biospecimen Retention:   Samples Without DNA
Thirty (n=30) healthy, non-smoking male and female volunteers between the ages of 18-50 will be included in this study. If all inclusion/exclusion criteria are met, a blood collection of 104 ml will be obtained and the study visit will be completed. If eligible, a volunteer may participate in this study up to four separate times, but not more than two times in the same week.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal, healthy, non-smoking, male and non-pregnant female volunteers between the ages of 18 - 50
Criteria

Inclusion Criteria:

  • age between 18-50
  • non-pregnant females
  • non-smoking males and females
  • in good health as based on medical history

Exclusion Criteria:

  • Subjects with any medical condition, which according to the investigator, may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
  • Subjects who have received an experimental drug within 30 days prior to the study
  • Subjects who have taken medications at least two weeks prior to the study. Subjects using hormonal birth control, however, will not be an exclusionary criterion.
  • Subjects who have taken aspirin or aspirin containing products for at least two weeks prior to the study.
  • Subjects who have taken acetaminophen, NSAIDs, COX-2 inhibitors (OTC or prescription) for at least two weeks prior to the study.
  • Subjects who are consuming any type of tobacco product(s).
  • Subjects who consume high doses of antioxidant vitamins daily (vitamin C> 1000mg, Vitamin E> 400IU, Beta Carotene> 1000IU, Vitamin A> 5000IU, Selenium> 200mcg, Folic Acid> 1mg) for the two weeks prior to the start of the study and throughout the study.
  • Subjects who consume alcohol, caffeine or high fat food 24 hours prior to the study.

    • Pregnant female subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095288


Locations
Layout table for location information
United States, Pennsylvania
The Clinical Translational Research Center (CTRC) at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Eli Lilly and Company
Investigators
Layout table for investigator information
Principal Investigator: Garret A FitzGerald, MD University of Pennsylvania
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02095288    
Other Study ID Numbers: 818658
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Pennsylvania:
lipidomics
in vitro human whole blood assay
anti-inflammatory drugs
Lipidomics screening of anti-inflammatory drugs