SIGA-246 to Treat Smallpox
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|ClinicalTrials.gov Identifier: NCT00303225|
Recruitment Status : Withdrawn
First Posted : March 15, 2006
Last Update Posted : July 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Vaccinia||Drug: Vaccine: SIGA-246||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303225
|United States, Maryland|
|National Institute of Allergy and Infectious Diseases (NIAID)|
|Bethesda, Maryland, United States, 20892|