Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite

PHASE2CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

August 15, 2021

Primary Completion Date

June 7, 2023

Study Completion Date

June 8, 2023

Conditions
SnakebitesEnvenomingEnvenoming, SnakeEnvenomation, Snake
Interventions
DRUG

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.

DRUG

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."

DRUG

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.

Trial Locations (16)

27710

Duke University Hospital Durham, NC, Durham

30912

Agusta University Medical Center, Augusta

32209

University of Florida Health, Jacksonville

39216

University of Mississippi Medical Center - Jackson, Jackson

40536

University of Kentucky Chandler Medical Center, Lexington

71103

LSU LA Poison Control Center, Shreveport

85724

University of Arizona, Tucson

92354

Loma Linda University Medical Center, Loma Linda

575002

Father Muller medical College Hospital, Mangalore

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Ophirex, Inc.

INDUSTRY

NCT04996264 - Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite | Biotech Hunter | Biotech Hunter