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Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial

NCT03318783 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-22

Study results available
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Summary

Soluble epoxide hydrolase (sEH) is the metabolizing enzyme of epoxyeicosatrienoic acids (EETs), which may play a role in reducing neuroinflammation and regulating cerebral blood flow after subarachnoid hemorrhage (SAH). Hypotheses: Pharmacologic inhibition of the sEH enzyme is safe and will result in increased EETs availability in the blood and cerebrospinal fluid. This study is a double-blind, placebo-controlled, phase 1b randomized trial to evaluate the safety and efficacy of GSK2256294, a novel soluble epoxide hydrolase inhibitor in patients with aneurysmal SAH.

Conditions

  • Subarachnoid Hemorrhage, Aneurysmal
  • Delayed Cerebral Ischemia
  • Vasospasm, Cerebral
  • Endothelial Dysfunction

Interventions

DRUG

GSK2256294

GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.

DRUG

Placebo

Placebo will be administered in a single dose once daily enteral for a duration of 10 days.

Sponsors & Collaborators

  • Foundation for Anesthesia Education and Research

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Ross Martini, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2019-04-03
Completion
2020-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318783 on ClinicalTrials.gov