NCT02474589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

June 19, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 28, 2017

Completed
Last Updated

November 28, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

June 1, 2015

Results QC Date

July 27, 2017

Last Update Submit

October 20, 2017

Conditions

Smallpox

Keywords

Treatmentorthopoxvirussmallpox

Outcome Measures

Primary Outcomes (1)

  • To Determine the Number of Participants With Adverse Events

    To determine the safety and tolerability of oral tecovirimat

    45 days

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Drug: tecovirimat

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

tecovirimatDRUG

Study is based on Animal Regulatory Rule

Also known as: ST-246
Active
PlaceboOTHER

Does not apply

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Paradigm Research

Redding, California, 96001, United States

Location

Paradigm Research

San Diego, California, 92117, United States

Location

Johnson County Clinical Trials

Lenexa, Kansas, 66219, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research LLC

St Louis, Missouri, 63141, United States

Location

Meridien Clinical Research

Omaha, Nebraska, 68134, United States

Location

Medical Research South

Charleston, South Carolina, 29407, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Related Publications (1)

  • Grosenbach DW, Honeychurch K, Rose EA, Chinsangaram J, Frimm A, Maiti B, Lovejoy C, Meara I, Long P, Hruby DE. Oral Tecovirimat for the Treatment of Smallpox. N Engl J Med. 2018 Jul 5;379(1):44-53. doi: 10.1056/NEJMoa1705688.

    PMID: 29972742DERIVED

MeSH Terms

Conditions

Smallpox

Interventions

tecovirimat

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Results Point of Contact

Title
Dennis E Hruby, PhD, Chief Scientific Officer
Organization
SIGA Technologies
dhruby@siga.com
541-753-2000

Study Officials

  • Dennis Hruby, Ph.D.

    SIGA Technologies, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 18, 2015

Study Start

June 19, 2015

Primary Completion

August 24, 2016

Study Completion

August 24, 2016

Last Updated

November 28, 2017

Results First Posted

November 28, 2017

Record last verified: 2017-10

Locations

US(11)