Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
- Registration Number
- NCT00431951
- Lead Sponsor
- SIGA Technologies
- 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 volunteers.
- 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 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Healthy volunteers
- Ability to Consent
- Not taking any other medication
- Adequate venous access
- Using adequate birth control
Subject
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description ST-246 ST-246 250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days placebo Placebo Placebo to match ST-246
- Primary Outcome Measures
Name Time Method Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table Days 1, 6, 14-16, 21-24, 28-31, and 51-53 Evaluated safety parameters included:
1. physical examination/vital signs
2. electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)
3. laboratory safety tests (hematology, chemistry, urinalysis)
4. adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in DAIDS AE Table)and ST-246-related, they were considered severe and significant, respectively.
- Secondary Outcome Measures
Name Time Method Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax Day 21 Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax Day 21 Tmax: Time to reach maximum drug concentration in plasma calculated from \[plasma\] versus time profiles.
Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½ Day 21 t½: Observed terminal elimination half-life determined after the last dose on Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau Day 21 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
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24) Day 21 Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21
Trial Locations
- Locations (1)
Orlando Clinical Research
🇺🇸Orlando, Florida, United States