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

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

Detailed Description
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Pharmacokinetics and safety and tolerability data will be collected.

Official Title
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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

Conditions
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Smallpox

Intervention / Treatment
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* Drug: tecovirimat
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>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<br>* Study is based on Animal Regulatory Rule<br>* Other names: ST-246;|
| Placebo Comparator: Placebo<br>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<br>* Does not apply<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, orthopoxvirus, smallpox