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

Phase 3

Completed

Conditions: Smallpox

Interventions: Drug: tecovirimat
Other: Placebo

Registration Number: NCT02474589

Lead Sponsor: SIGA Technologies

Brief Summary: 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: Pharmacokinetics and safety and tolerability data will be collected.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 449

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	tecovirimat	600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
Placebo	Placebo	matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects

Primary Outcome Measures

Name	Time	Method
To Determine the Number of Participants With Adverse Events	45 days	To determine the safety and tolerability of oral tecovirimat

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (9): Paradigm Research
🇺🇸
San Diego, California, United States
Sundance Clinical Research LLC
🇺🇸
Saint Louis, Missouri, United States
Center for Pharmaceutical Research
🇺🇸
Kansas City, Missouri, United States
Meridien Clinical Research
🇺🇸
Omaha, Nebraska, United States
Benchmark Research
🇺🇸
Fort Worth, Texas, United States
Medical Research South
🇺🇸
Charleston, South Carolina, United States
Coastal Clinical Research, Inc.
🇺🇸
Mobile, Alabama, United States
Johnson County Clinical Trials
🇺🇸
Lenexa, Kansas, United States
Heartland Research Associates, LLC
🇺🇸
Newton, Kansas, United States