Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303225
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2006-03-14
Brief Title:
SIGA-246 to Treat Smallpox
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Ascending Single-Dose Phase I Trial of the Anti-Orthopoxvirus Compound SIGA-246 in Healthy Volunteers
Status:
WITHDRAWN
Status Verified Date:
2006-08-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 15 2 25 3 35 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
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 15 2 25 3 35 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
Detailed Description:
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 Cmax Tmax t12 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0114 | None | None | None |