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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 24, 2016

Detailed Description

Pharmacokinetics and safety and tolerability data will be collected.

Interventions

  • Drug: tecovirimat
    • Study is based on Animal Regulatory Rule
  • Other: Placebo
    • Does not apply

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • To Determine the Number of Participants With Adverse Events
    • Time Frame: 45 days
    • To determine the safety and tolerability of oral tecovirimat

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • SIGA Technologies
  • Collaborator
    • Biomedical Advanced Research and Development Authority
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dennis Hruby, Ph.D., Study Director, SIGA Technologies, Inc.

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