Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Lead Sponsor:
SIGA Technologies
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Orthopoxviral Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 day...
Detailed Description
This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when ad...
Eligibility Criteria
Inclusion
- 18 - 75 yrs
- Healthy volunteer
- Ability to consent
- Available for clinical follow-up for study
- Not taking other medications
- Adequate venous access
- Using adequate birth control; negative pregnancy test
- Able and willing to avoid alcohol for screening and study duration
Exclusion
- Inability to swallow study medication
- Pregnant or breast-feeding
- Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
- History of drug allergy that contraindicates study participation
- Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
- Clinically abnormal ECG
- Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
- Cannot or will not do physical exercise 24 hrs before and after PK days
- Will not consume grapefruit/grapefruit juice during study
- Vaccination within 2 wks of screening, or planned before Day 42 of study
- Treatment with prednisone or equivalent immunosuppressant/modulatory drug \<3 mths before screening
- Clinically significant physical exam and lab results \<2weeks from 1st study drug dose
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00907803
Start Date
June 1 2009
End Date
January 1 2010
Last Update
September 21 2010
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Apex Research Institute
Santa Ana, California, United States, 92705
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
Hawaii Clinical Research Center
Honolulu, Hawaii, United States, 96813