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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474589
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
SIGA Technologies

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

Condition or disease Intervention/treatment Phase
Smallpox Drug: tecovirimat Other: Placebo Phase 3

Detailed Description:
Pharmacokinetics and safety and tolerability data will be collected.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 19, 2015
Actual Primary Completion Date : August 24, 2016
Actual Study Completion Date : August 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety Smallpox
Drug Information available for: Tecovirimat

Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. To Determine the Number of Participants With Adverse Events [ Time Frame: 45 days ]
    To determine the safety and tolerability of oral tecovirimat


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474589


Locations
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United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, California
Paradigm Research
Redding, California, United States, 96001
Paradigm Research
San Diego, California, United States, 92117
United States, Kansas
Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
Heartland Research Associates, LLC
Newton, Kansas, United States, 67114
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Sundance Clinical Research LLC
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Meridien Clinical Research
Omaha, Nebraska, United States, 68134
United States, South Carolina
Medical Research South
Charleston, South Carolina, United States, 29407
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Benchmark Research
Fort Worth, Texas, United States, 76135
Sponsors and Collaborators
SIGA Technologies
Biomedical Advanced Research and Development Authority
Investigators
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Study Director: Dennis Hruby, Ph.D. SIGA Technologies, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SIGA Technologies
ClinicalTrials.gov Identifier: NCT02474589    
Other Study ID Numbers: SIGA-246-008
First Posted: June 18, 2015    Key Record Dates
Results First Posted: November 28, 2017
Last Update Posted: November 28, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by SIGA Technologies:
Treatment
orthopoxvirus
smallpox
Additional relevant MeSH terms:
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Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections