A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat
NCT ID: NCT02474589
Last Updated: 2017-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
449 participants
INTERVENTIONAL
2015-06-19
2016-08-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
tecovirimat
Study is based on Animal Regulatory Rule
Placebo
matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
Placebo
Does not apply
Interventions
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tecovirimat
Study is based on Animal Regulatory Rule
Placebo
Does not apply
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
SIGA Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Hruby, Ph.D.
Role: STUDY_DIRECTOR
SIGA Technologies, Inc.
Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Paradigm Research
Redding, California, United States
Paradigm Research
San Diego, California, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Sundance Clinical Research LLC
St Louis, Missouri, United States
Meridien Clinical Research
Omaha, Nebraska, United States
Medical Research South
Charleston, South Carolina, United States
Benchmark Research
Austin, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Countries
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References
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Grosenbach DW, Honeychurch K, Rose EA, Chinsangaram J, Frimm A, Maiti B, Lovejoy C, Meara I, Long P, Hruby DE. Oral Tecovirimat for the Treatment of Smallpox. N Engl J Med. 2018 Jul 5;379(1):44-53. doi: 10.1056/NEJMoa1705688.
Other Identifiers
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SIGA-246-008
Identifier Type: -
Identifier Source: org_study_id