Viewing Study NCT04464070



Ignite Creation Date: 2024-05-06 @ 2:55 PM
Last Modification Date: 2024-10-26 @ 1:39 PM
Study NCT ID: NCT04464070
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-06-14
First Post: 2020-07-01

Brief Title: Pathways of Eicosanoid Metabolism
Sponsor: Vanderbilt University
Organization: Vanderbilt University

Study Overview

Official Title: Novel Pathways of Eicosanoid Metabolism
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Prostaglandins are important signaling compounds formed from arachidonic acid The enzymes that form prostaglandins cyclooxygenase-1 and -2 are the targets of non-steroidal anti-inflammatory drugs NSAIDs Because prostaglandins are very unstable in the body they can not be measured directly Instead their metabolites are isolated from urine or blood and quantified as markers of formation of the parent active compounds

The investigators are testing the hypothesis that there is a previously unrecognized metabolic pathway between two prostaglandins The investigators hypothesize that prostaglandin D2 PGD2 in addition to its known metabolism to PGD-M is also metabolized to 11-dehydro-thromboxane B2 11-dehydro-TxB2
Detailed Description: The objective of this study is to determine whether PGD2 is metabolized to 11-dehydro-TxB2 in humans Because the levels of PGD2 and its metabolite PGD-M are low in human urine the investigators will use the model of niacin-induced flushing which is associated with a increased release of PGD2 from skin cells It has been demonstrated that increased formation of PGD2 is associated with increased levels of urinary 11-dehydro-TxB2 in patients with mastocytosis

In order to test whether niacin-induced biosynthesis of PGD2 is associated with formation of 11-dehydro-TxB2 the investigators will measure prostaglandin metabolites in blood and urine of volunteers receiving niacin In addition subjects will be treated with low or high dose aspirin prior to niacin to analyze the contribution of cyclooxygenase enzymes to biosynthesis of PGD2

Arm 1 Subjects will receive 500 mg niacin The subjects will collect urine 3-10 ml each before niacin and every one-two hours after niacin for 10 h Subjects will have blood drawn 2 teaspoons before and at 05-1 h after niacin

Arm 2 Subjects will take 81 mg aspirin 1 tablet of low-dose aspirin daily for 7 days before niacin Urine collection will be before and after aspirin before niacin and then in intervals as in arm 1 There will be a blood collection before niacin and 05-1 h after niacin

Arm 3 Subjects will take 325 mg aspirin 1 tablet of regular strength aspirin daily for 7 days before niacin Urine collection will be before and after aspirin before niacin and then in intervals as in arm 1

Arm 4 Subjects will be infused with 10 μg of deuterated PGD2 in a forearm vein over the course of 30 min Subjects will collect a urine sample before and every two hours after deuterated PGD2 for 10 h

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None