95
Participants
Start Date
August 15, 2021
Primary Completion Date
June 7, 2023
Study Completion Date
June 8, 2023
Varespladib Methyl
Varespladib-methyl (LY333013) is an IR, oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration. Scaled pediatric doses of varespladib-methyl (LY333013) are supplied as 50 mg IR capsules for oral administration.
Placebo
"The oral placebo is supplied as a white film-coated oval tablet to match the appearance of the varespladib-methyl 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate.~Placebo for scaled pediatric dosing is supplied as an IR capsule to match the varespladib-methyl 50 mg capsule, and contains the excipients lactose monohydrate, microcrystalline cellulose, and magnesium stearate."
Standard of care (SOC)
SOC (including antivenom) will continue to be administered throughout the subject's participation in the study according to the protocol and the judgment of the Investigator.
Duke University Hospital Durham, NC, Durham
Agusta University Medical Center, Augusta
University of Florida Health, Jacksonville
University of Mississippi Medical Center - Jackson, Jackson
University of Kentucky Chandler Medical Center, Lexington
LSU LA Poison Control Center, Shreveport
University of Arizona, Tucson
Loma Linda University Medical Center, Loma Linda
Father Muller medical College Hospital, Mangalore
Government medical College, Kozhikode
K R Hospital Mysore medical College and Research Institute, Mysore
Jubilee Mission Medical College and Research Institute, Thrissur
Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry
S.P. Medical College Snakebite Research Cell, Bikaner
Calcutta National Medical College, Kolkata
Postgraduate Institute of Medical Education and Research, Chandigarh
Lead Sponsor
Collaborators (1)
Premier Research Group plc
UNKNOWN
Ophirex, Inc.
INDUSTRY