NCT00907803Phase 2Completed

Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246

Primary completion2010-01ACTUAL

Enrollment107ACTUAL

Source updated2026-09-11Values from available record

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Conditions: Orthopoxviral Disease
Interventions: type: DRUG; name: ST-246 400 mg; otherNames: Tecovirimat; type: DRUG; name: ST-246 600 mg; otherNames: Tecovirimat; type: DRUG; name: Placebo
Primary outcomes: measure: Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.; description: Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.; timeFrame: Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose
History coverage: Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.