|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | SIGA Technologies |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | SIGA Technologies |
| ClinicalTrials.gov Identifier: | NCT00907803 |
Purpose
Enroll ~112 male/female subjects to whom either ST-246 (400 or 600mg) or placebo will be given for 14 days to assess the safety, tolerability and pharmacokinetics of ST-246.
| Condition | Intervention | Phase |
|---|---|---|
|
Orthopoxviral Disease |
Drug: ST-246 400 mg Drug: ST-246 600 mg Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Assess Safety, Tolerability, and PK of the Anti-Orthopoxvirus Compound ST-246 When Administered as a Single Daily Oral Dose for 14 Days in Volunteers in the Fed State |
| Enrollment: | 112 |
| Study Start Date: | June 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
ST-246 400 mg: Experimental
ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days
|
Drug: ST-246 400 mg
Capsules, 400 mg daily for 14 days
|
|
ST-246 600 mg: Experimental
ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days
|
Drug: ST-246 600 mg
Capsules, 600 mg daily for 14 days
|
|
Placebo: Placebo Comparator
Matching Placebo capsules, Orally Once Daily for 14 days
|
Drug: Placebo
Capsules, once daily for 14 days
|
This study is primarily a safety study which will also gather information on the pharmacokinetics of ST-246 to support the choice of final dose to be used in expanded pivotal safety trials.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
History of clinically significant conditions including:
Lab results <14 days prior to first study drug dose, as follows:
Contacts and Locations| United States, California | |
| Apex Research Institute | |
| Santa Ana, California, United States, 92705 | |
| United States, Florida | |
| Orlando Clinical Research Center | |
| Orlando, Florida, United States, 32809 | |
| United States, Hawaii | |
| Hawaii Clinical Research Center | |
| Honolulu, Hawaii, United States, 96813 | |
| Principal Investigator: | Dennis E Hruby, PhD | SIGA Technologies |
More Information
| Responsible Party: | SIGA Technologies, Inc. ( Annie Frimm, Vice President Regulatory Affairs ) |
| Study ID Numbers: | SIGA-246-004, DMID 08-0055 |
| Study First Received: | May 21, 2009 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00907803 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Orthopoxvirus Smallpox This is a safety study only ST-246 is being studied for treatment of Orthopoxviruses |