NCT02474589

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: SIGA Technologies · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Pharmacokinetics and safety and tolerability data will be collected.

Conditions

• Smallpox

Interventions

Type	Name	Description
DRUG	tecovirimat	Study is based on Animal Regulatory Rule
OTHER	Placebo	Does not apply

Timeline

• Start date: 2015-06-19
• Primary completion: 2016-08-24
• Completion: 2016-08-24
• First posted: 2015-06-18
• Last updated: 2017-11-28
• Results posted: 2017-11-28

Locations

11 sites across 1 country: United States