A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat (SIGA246-008)

October 20, 2017 updated by: SIGA Technologies

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pharmacokinetics and safety and tolerability data will be collected.

Study Type

Interventional

Enrollment (Actual)

449

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • California
      • Redding, California, United States, 96001
        • Paradigm Research
      • San Diego, California, United States, 92117
        • Paradigm Research
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clinical Trials
      • Newton, Kansas, United States, 67114
        • Heartland Research Associates, LLC
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center For Pharmaceutical Research
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridien Clinical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical Research South
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 80 years old, inclusive
  • Available for clinical follow-up for the duration of the study
  • Able and willing to give informed consent
  • In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for the last 2 years
  • Able to comply with dietary requirements throughout the study drug dosing period
  • Adequate venous access for those individuals participating in PK testing
  • PE and laboratory results without clinically significant findings within the 14 days before receipt of study drug
  • Agree not to drink alcohol from the beginning of the Screening Period through the completion of the Day 28 Follow up Visit
  • Agree not to use any nicotine products, including electronic vapor cigarettes, nicotine patches or nicotine gum for at least 30 days before the Day 1 Visit and through completion of the Day 15 Dosing complete Visit
  • Agree not to consume caffeine during all study visits, including overnight stays if participating in PK subset
  • Agree not to receive any immunizations/vaccinations
  • Agree not to take herbal products
  • Able and willing to refrain from taking any prescriptions and nonprescription medications with exceptions
  • For women of childbearing potential, negative serum and urine pregnancy testing
  • If male, agree not to donate sperm
  • Meet 1 of the following criteria: The subject or their partner has undergone surgical sterilization; the subject is postmenopausal; the subject agrees to be abstinent; the subject agrees to consistently use a method of approved birth control.

Exclusion Criteria:

  • Pregnant or breast-feeding or planning pregnancy
  • Have a history of any clinically significant conditions
  • Have any limitation of activity related to cardiac disease
  • Have a bleeding disorder diagnosed by a doctor, or a history of significant bruising or bleeding with intramuscular injections or blood draws
  • Currently using certain medications
  • Have a malignancy that is active or a treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study
  • Have a history of seizure
  • Have a clinically significant blood dyscrasia
  • Have a history of drug allergy that contraindicates participation in the trial
  • Have a medical, psychiatric, or social condition or any occupational reason, or other responsibility that in the judgment of the investigator would render the subject unable to comply with the protocol
  • Have an inability to swallow medication
  • Have a clinically significant abnormal ECG
  • Have participated in a clinical trials within 30 days of study entry or planning to participate in any experimental treatment study during the study period
  • Have a history or current drug or alcohol abuse
  • Have received immunizations/vaccines
  • Have a current clinically significant acute bacterial, fungal, or mycobacterial infection requiring administration of systemic antibiotics
  • Have known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection with the exception of clinically significant dermal infections
  • Have known hepatitis B or C infection, or positive test result
  • Have known HIV infection or AIDS or a positive test for HIV
  • Have a current clinically significant viral infection
  • Have known clinically significant chronic viral infection
  • have received treatment with greater than 20 mg prednisone or equivalent dose or any immunosuppressant or immunomodulary medication
  • Have abnormal laboratory testing during screening
  • Have a greater than or equal than 20% risk of suffering a major cardiovascular event
  • Have been previously enrolled in this or any clinical trial involving tecovirimat

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
Drug: tecovirimat
Study is based on Animal Regulatory Rule
Other Names:
  • ST-246
Placebo Comparator: Placebo
matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
Other: Placebo
Does not apply

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Determine the Number of Participants With Adverse Events
Time Frame: 45 days
To determine the safety and tolerability of oral tecovirimat
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SIGA Technologies

Collaborators

Biomedical Advanced Research and Development Authority

Investigators

  • Study Director: Dennis Hruby, Ph.D., SIGA Technologies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2015

Primary Completion (Actual)

August 24, 2016

Study Completion (Actual)

August 24, 2016

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

October 20, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGA-246-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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