Status:
COMPLETED
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
Lead Sponsor:
SIGA Technologies
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed vo...
Detailed Description
This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 s...
Eligibility Criteria
Inclusion
- Subject
- Healthy volunteers
- Ability to Consent
- Not taking any other medication
- Adequate venous access
- Using adequate birth control
- Subject
Exclusion
- Inability to swallow study medication.
- Pregnant or breastfeeding
- Received experimental drug within 30 days of study entry or will participate in any experimental study during the study period.
- Current drug abuse, alcohol abuse, or homelessness.
- Taking concomitant medication
- Lactose Intolerance
- Medical condition; e.g., asthma, diabetes, thyroid disease, angioedema, BMI \>35 or \<18, hypertension, bleeding disorder, malignancy, seizure, neutropenia, Hepatitis B or C, HIV or AIDS.
- Any condition, occupational reason or other responsibility that, in the judgment of the Investigator, would jeopardize the safety or rights of a volunteer, or render the subject unable to comply with the protocol
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00431951
Start Date
February 1 2007
End Date
February 1 2008
Last Update
July 27 2017
Active Locations (1)
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1
Orlando Clinical Research
Orlando, Florida, United States, 32809