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NCT00907803 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
A Phase 2 study, sponsored by SIGA Technologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
NCT00907803: Completed Phase 2 study, sponsored by SIGA Technologies.
NCT00907803 is a Phase 2 study that has completed, run by SIGA Technologies. The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00907803, a Phase 2 study, has completed, sponsored by SIGA Technologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG ST-246 400 mg
- DRUG ST-246 600 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00907803 record still lists
NCT00907803 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00907803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00907803 about?
NCT00907803 is a clinical study titled "Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246". 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 expande...
What is the current status of trial NCT00907803?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2009-06. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00907803?
The interventions under investigation include: Placebo (DRUG), ST-246 400 mg (DRUG), ST-246 600 mg (DRUG).
Who is sponsoring clinical trial NCT00907803?
This trial is sponsored by SIGA Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00907803's enrollment target sits among peer trials
107 646th of 2000 higher than 1,353 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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