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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 is a Phase 2 study that has completed, run by SIGA Technologies. The registered enrollment target is 107 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG ST-246 400 mg
  • DRUG ST-246 600 mg

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2009-06
Est. Completion 2010-01
Phase Phase 2

Sponsor

SIGA Technologies

8 total trials

What the Registry Record Tells You About NCT00907803

The ClinicalTrials.gov registry entry for NCT00907803 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SIGA Technologies, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00907803 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.