a trial to assess the safety, tolerability, and pharmacokinetics of the anti-orthopoxvirus compound tecovirimat

Conditions: 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.

pharmacokinetics and safety and tolerability data will be collected.

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

Keywords: treatment orthopoxvirus smallpox