At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
ST-246 400 mg +2 moredrug
Likely dose
ST-246 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ST-246 400 mg, ST-246 600 mg, and 1 other intervention for Orthopoxviral Disease. Completed, enrolled 107 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrthopoxviral Disease
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartJun 2009
Primary CompletionJan 2010
TodayJul 2026
First PostedMay 25, 2009
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.1 years ago
Interventions
ST-246 400 mgdrug
Capsules, 400 mg daily for 14 days
ST-246 600 mgdrug
Capsules, 600 mg daily for 14 days
Placebodrug
Capsules, once daily for 14 days