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COMPLETED
NCT02474589
PHASE3

A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat

Sponsor: SIGA Technologies

View on ClinicalTrials.gov

Summary

Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.

Official title: An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

449

Start Date

2015-06-19

Completion Date

2016-08-24

Last Updated

2026-09-11

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

tecovirimat

Study is based on Animal Regulatory Rule

OTHER

Placebo

Does not apply

Locations (11)

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Paradigm Research

Redding, California, United States

Paradigm Research

San Diego, California, United States

Johnson County Clinical Trials

Lenexa, Kansas, United States

Heartland Research Associates, LLC

Newton, Kansas, United States

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Sundance Clinical Research LLC

St Louis, Missouri, United States

Meridien Clinical Research

Omaha, Nebraska, United States

Medical Research South

Charleston, South Carolina, United States

Benchmark Research

Austin, Texas, United States

Benchmark Research

Fort Worth, Texas, United States