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NCT00431951 · ClinicalTrials.gov registry record · Phase 1
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
A Phase 1 study of Healthy, sponsored by SIGA Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00431951: Completed Phase 1 study of Healthy, sponsored by SIGA Technologies.
NCT00431951 is a Phase 1 study of Healthy that has completed, run by SIGA Technologies. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00431951, a Phase 1 study of Healthy, has completed, sponsored by SIGA Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
Primary Outcome
Evaluated safety parameters included: 1. physical examination/vital signs 2. electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett) 3. laboratory safety tests (hematology, chemistry, urinalysis) 4. adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ST-246
Study Locations (1)
Florida
- Orlando Clinical Research - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
What the finished NCT00431951 record still lists
NCT00431951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00431951 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00431951 about?
NCT00431951 is a clinical study titled "Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers". The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
What is the current status of trial NCT00431951?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2007-02. Estimated completion is 2008-02.
What conditions does trial NCT00431951 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00431951?
The interventions under investigation include: Placebo (DRUG), ST-246 (DRUG).
Who is sponsoring clinical trial NCT00431951?
This trial is sponsored by SIGA Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00431951 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00431951's enrollment target sits among peer trials
30 678th of 1090 higher than 363 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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