SIGA-246 to Treat Smallpox
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Ascending Single-Dose, Phase I Trial of the Anti-Orthopoxvirus Compound SIGA-246 in Healthy Volunteers|
|Study Start Date:||March 13, 2006|
|Estimated Study Completion Date:||August 4, 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303225
|United States, Maryland|
|National Institute of Allergy and Infectious Diseases (NIAID)|
|Bethesda, Maryland, United States, 20892|