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 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.
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 administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
107
Capsules, 400 mg daily for 14 days
Capsules, 600 mg daily for 14 days
Capsules, once daily for 14 days
Apex Research Institute
Santa Ana, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, United States
Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.
Time frame: Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data
Time frame: Day 1 post-dose
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data
Time frame: Day 14 post-dose
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Tmax: Time to reach maximum drug concentration in plasma calculated from \[plasma\] versus time profiles
Time frame: Day 1 post-dose
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Tmax: Time to reach maximum drug concentration in plasma calculated from \[plasma\] versus time profiles
Time frame: Day 14 post-dose
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
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AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule
Time frame: Day 1 post-dose
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule
Time frame: Day 14 post-dose
Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½
t½: Observed terminal elimination half-life determined after the last dose on Day 14
Time frame: Day 14 post-dose