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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: Pharmacokinetics and safety and tolerability data will be collected.
Sponsor: SIGA Technologies

Current Primary Outcome: To determine the number of participants with Adverse Events [ Time Frame: 45 days ]

To determine the safety and tolerability of oral tecovirimat


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: SIGA Technologies

Dates:
Date Received: June 1, 2015
Date Started: June 19, 2015
Date Completion:
Last Updated: March 2, 2017
Last Verified: March 2017