Smallpox
Conditions
Keywords
Treatment, orthopoxvirus, smallpox
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.
Interventions
DRUGtecovirimat
Study is based on Animal Regulatory Rule
OTHERPlacebo
Does not apply
Sponsors
SIGA Technologies
Biomedical Advanced Research and Development Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Number of Participants With Adverse Events | 45 days | To determine the safety and tolerability of oral tecovirimat |
Countries
United States
Contacts
STUDY_DIRECTORDennis Hruby, Ph.D.
SIGA Technologies, Inc.
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
tecovirimat: Study is based on Animal Regulatory Rule | 359 |
| Placebo matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects
Placebo: Does not apply | 90 |
| Total | 449 |
Baseline characteristics
| Characteristic | Active | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 15.67 | 40.7 years STANDARD_DEVIATION 15.7 | 41.9 years STANDARD_DEVIATION 15.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 48 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 315 Participants | 400 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 101 Participants | 127 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 249 Participants | 311 Participants | 62 Participants |
| Region of Enrollment United States | 359 participants | 449 participants | 90 participants |
| Sex: Female, Male Female | 211 Participants | 265 Participants | 54 Participants |
| Sex: Female, Male Male | 148 Participants | 184 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 134 / 359 | 30 / 90 |
| serious Total, serious adverse events | 1 / 359 | 0 / 90 |
Outcome results
Primary
To Determine the Number of Participants With Adverse Events
To determine the safety and tolerability of oral tecovirimat
Time frame: 45 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | To Determine the Number of Participants With Adverse Events | 134 Participants |
| Placebo | To Determine the Number of Participants With Adverse Events | 30 Participants |