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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00303225 |
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:
Condition | Intervention | Phase |
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Vaccinia |
Drug: Vaccine: SIGA-246 |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 100 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2006 |
Historically, smallpox has been responsible for hundreds of millions of deaths. In 1980 the World Health Organization declared the global eradication of smallpox which was achieved through a surveillance and vaccination program using live virus vaccine. In spite of its eradication, the deliberate use of smallpox as a bioterrorist agent remains a threat. While there is an effective vaccine, there have been concerns regarding vaccine complications which have prevented universal vaccination in the absence of disease exposure. In addition, in the event of a smallpox outbreak vaccination may be ineffective in immunocompromised individuals and in those who were exposed to the virus more than 3 days prior to vaccination. Antiviral therapy may be able to supplement a vaccine, however, there are limitations of the currently available drug options. SIGA-246 is an oral medication that has been shown to be highly active against variola virus and has demonstrated safety in animal models. The primary objective of this study is to assess the safety and tolerability of SIGA-246 at various doses with a secondary objective of evaluating the pharmacokinetics of the drug. To achieve these objectives, 30 healthy volunteers will be enrolled into one of three dosing groups (500 mg, 1000 mg, or 2000 mg) to receive an oral, single dose of SIGA-246 or placebo.
In each of the three ascending dosing groups there will be 8 active drug recipients and 2 placebo recipients. Safety of the study agents will be assessed by history, physical, and laboratory evaluations. Pharmacokinetic endpoints include C(max), T(max), t(1/2), AUC, CI and urinary excretion.
Urine will be collected in 3 8-hour intervals and serial blood samples will be obtained after study agent administration.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
A participant must meet all of the following criteria:
Physical examination and laboratory results without clinically significant findings within the 28 days prior to receipt of study drug (i.e., satisfactorily completed screening).
Laboratory criteria within 28 days prior to receipt of study drug:
The participant or his or her partner has undergone surgical sterlization, or the participant agrees either to be abstinent (i.e., heterosexually inactive) or to consistently use two of the following non-hormonal methods of contraception within the 21 days prior to receipt of the study drug and throughout the duration of the study:
EXCLUSION CRITERIA:
A volunteer will be excluded if one or more of the following conditions apply:
Volunteer is on any concomitant medications, including over the counter medications or herbal supplements, for 14 days before the administration of the study agent.
Volunteer has a history of any clinically significant conditions including:
Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
Volunteer has:
Study ID Numbers: | 060114, 06-I-0114 |
Study First Received: | March 14, 2006 |
Last Updated: | October 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00303225 History of Changes |
Health Authority: | United States: Federal Government |
Biodefense Smallpox Monkeypox Vaccinia |
Prophylaxis Healthy Volunteer HV Smallpox |
Virus Diseases Smallpox Monkeypox Poxviridae Infections |
Vaccinia DNA Virus Infections Healthy |
Virus Diseases Poxviridae Infections Vaccinia DNA Virus Infections |