A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat (SIGA246-008)

SIGA Technologies

Status and phase: Completed; Phase 3

Conditions: Smallpox

Treatments: Other: Placebo; Drug: tecovirimat

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02474589

SIGA-246-008

Details and patient eligibility

About

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

Full description

Pharmacokinetics and safety and tolerability data will be collected.

Enrollment: 449 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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449 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects

Treatment:

Drug: tecovirimat

Placebo

Placebo Comparator group

Description:

matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects

Treatment:

Other: Placebo