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

Smallpox Clinical Trial

— SIGA246-008  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474589
• Other study ID #: SIGA-246-008
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2015
• Last updated: October 20, 2017
• Start date: June 19, 2015
• Est. completion date: August 24, 2016

Study information

• Verified date: October 2017
• Source: SIGA Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Pharmacokinetics and safety and tolerability data will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: August 24, 2016
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Smallpox

Intervention

Drug:
• tecovirimat
Study is based on Animal Regulatory Rule

Other:
• Placebo
Does not apply

Locations

Country	Name	City	State
United States	Benchmark Research	Austin	Texas
United States	Medical Research South	Charleston	South Carolina
United States	Benchmark Research	Fort Worth	Texas
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Johnson County Clinical Trials	Lenexa	Kansas
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Meridien Clinical Research	Omaha	Nebraska
United States	Paradigm Research	Redding	California
United States	Sundance Clinical Research LLC	Saint Louis	Missouri
United States	Paradigm Research	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
SIGA Technologies	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine the Number of Participants With Adverse Events	To determine the safety and tolerability of oral tecovirimat	45 days