Skip to main content
OpenTrials
Completed

NCT Number: NCT00431951

Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research

Orlando, Florida, 32809, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ST-246

Drug

250 mg, 400 mg or 800 mg capsules given once daily for 21 days

Other names: Tecovirimat

Placebo

Drug

Capsules to match experimental drug

Other names: Placebo to match ST-246

Primary outcomes

  1. 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

    Time frame: Days 1, 6, 14-16, 21-24, 28-31, and 51-53

    Evaluated safety parameters included:

    • physical examination/vital signs
    • electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)
    • laboratory safety tests (hematology, chemistry, urinalysis)
    • 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 outcomes

  1. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

    Time frame: Day 1

    Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data

  2. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

    Time frame: Day 6

    Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data

  3. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax

    Time frame: Day 21

    Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data

  4. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax

    Time frame: Day 1

    Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.

  5. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax

    Time frame: Day 6

    Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.

  6. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax

    Time frame: Day 21

    Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.

  7. Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½

    Time frame: Day 21

    t½: Observed terminal elimination half-life determined after the last dose on Day 21

  8. Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau

    Time frame: Day 1

    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

  9. Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau

    Time frame: Day 6

    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

  10. Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau

    Time frame: 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

  11. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)

    Time frame: Day 1

    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

  12. Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

SIGA Technologies

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Acronym: SIGA-246-002

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2007
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.