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Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Sponsor: SIGA Technologies
Summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.
Official title: Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Assess Safety, Tolerability, and PK of the Anti-Orthopoxvirus Compound ST-246 When Administered as a Single Daily Oral Dose for 14 Days in Volunteers in the Fed State
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
107
Start Date
2009-06
Completion Date
2010-01
Last Updated
2026-09-11
Healthy Volunteers
Yes
Conditions
Interventions
ST-246 400 mg
Capsules, 400 mg daily for 14 days
ST-246 600 mg
Capsules, 600 mg daily for 14 days
Placebo
Capsules, once daily for 14 days
Locations (3)
Apex Research Institute
Santa Ana, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, United States