Clinical trial NCT00431951: Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
Official title: Double-blind, Randomized, Placebo-controlled, Escalating, Multiple-dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetics of ST-246 Administered as a Single Daily Dose for 21 Days in Healthy, Non-fasted Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: SIGA Technologies
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2007-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Subject Inclusion Criteria:

* Healthy volunteers
* Ability to Consent
* Not taking any other medication
* Adequate venous access
* Using adequate birth control

Subject Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Days 1, 6, 14-16, 21-24, 28-31, and 51-53
Secondary outcomes:
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
timeFrame: Day 1
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
timeFrame: Day 6
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
timeFrame: Day 21
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
timeFrame: Day 1
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
timeFrame: Day 6
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
timeFrame: Day 21
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½
timeFrame: Day 21
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
timeFrame: Day 1
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
timeFrame: Day 6
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
timeFrame: Day 21
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)
timeFrame: Day 1
measure: Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)
timeFrame: Day 21
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research
state: Florida
Study officials:
affiliation: Orlando Clinical Research
name: Thomas C Marbury, MD
role: PRINCIPAL_INVESTIGATOR
References: