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

Pharmacokinetics and safety and tolerability data will be collected.

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