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SIGA-246 to Treat Smallpox

NCT00303225 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will test an experimental antiviral drug called SIGA-246 for use against the smallpox virus (variola). Although smallpox has been universally eradicated, it could possibly be brought back as a bioweapon. In the event of a smallpox attack, it would be best to have an antiviral medication in addition to the smallpox vaccine. SIGA-246 has shown to have activity against other viruses from the same family (orthopoxvirus) that smallpox belongs to.

Healthy volunteers who are 18-50 years of age and are not pregnant or breastfeeding may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and an electrocardiogram.

Participants are randomly assigned to receive a one-time dose of SIGA-246 (either 500 mg, 1000 mg, or 2000 mg) or a placebo (sugar pill) taken by mouth. They report to the clinic in the morning for the following procedures:

* Insertion of intravenous (IV) line in the forearm.
* Blood and urine tests before taking the study drug.
* Drug administration within 30 minutes of eating a light breakfast.
* Blood sampling from the IV line at 30 minutes and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 and 6, 10 and 12 hours after taking SIGA-246 to determine how the drug is absorbed, distributed, broken down and excreted. Samples are also collected by needle stick at 24 and 48 hours for the same tests.
* Electrocardiogram at 2 hours and 24 hours after taking SIGA-246.
* 24-hour urine collection after taking the SIGA-246.
* Complete diary card at home for 7 days after taking the SIGA-246.
* Follow-up visits at about 2 weeks and about 4 weeks after taking SIGA-246.
* Checks for health changes or problems at every visit.

Conditions

  • Vaccinia

Interventions

DRUG

Vaccine: SIGA-246

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-13
Completion
2006-08-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00303225 on ClinicalTrials.gov