A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat
Condition: Smallpox
MeSH terms: Smallpox
Intervention: tecovirimat; Placebo
Intervention description: Study is based on Animal Regulatory Rule; Does not apply
Intervention MeSH terms: Tecovirimat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Treatment; orthopoxvirus; smallpox

Summary:

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

Eligibility 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