140
Participants
Start Date
May 30, 2023
Primary Completion Date
November 28, 2024
Study Completion Date
February 24, 2025
Varespladib intravenous form
This is a lyophilized drug contained in 100 mg vials to be reconstituted in Water for Injection (WFI), followed by dilution into 0.9% Sodium Chloride Injection.
varespladib-methyl- oral form
Varespladib-methyl (LY333013) is an immediate-release, oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration.
Placebo intravenous form
The intravenous placebo will be saline (0.9%). Blinding will be ensured by covering the bag containing the investigational product with opaque covers.
Placebo - oral form
Oral placebo is supplied as a white film-coated oval tablet to match the appearance of the LY333013 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate
Duke University Medical Center, Durham
UF Health Shands Hospital, Gainesville
University of South Florida/Tampa General Hospital, Tampa
Emergency Medicine, University of Kentucky, Lexington
UT Health San Antonio, San Antonio
Texas Tech University Health Sciences Center El Paso, El Paso
Banner University Medical Center - Phoenix, Phoenix
Arizona Poison & Drug Information Center, Tucson
Desert Regional Medical Center, Palm Springs
Antelope Valley Medical Center, Rosamond
Lead Sponsor
Ophirex, Inc.
INDUSTRY