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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)