SmallpoxPhase 4NCT04392739
Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG
A Phase 4 study testing Tpoxx in people with Smallpox, run by SIGA Technologies at 1 site in United States.
Trial summary
Safety and PK study in adults weighing more than 120 kg Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- Tpoxx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2019to 5 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female between 18 and 50 years of age, inclusive.
- Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to dosing on Day 1.
- Women of childbearing potential, have a negative β human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 before receipt of study drug, and meet 1 of the following criteria:
- The subject or their partner has undergone surgical sterilization
- The subject is postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle-stimulating hormone level >40 IU/mL
- The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious order)
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- The subject agrees to consistently use 1 of the following methods of contraception from the beginning of screening (which they had been consistently using for at least 30 days before the first dose of study drug) through 30 days after the last dose of study drug:
- Condoms, male or female, with a spermicide NOTE: For male subjects, condoms must be used for 90 days after the last dose of study drug.
- Diaphragm or cervical cap with spermicide
- Intrauterine device with spermicide
- Oral contraceptives or other hormonal methods NOTE: Subject must agree to use an additional nonhormonal method of contraception in conjunction with oral contraceptives.
- Male sexual partner who had undergone a vasectomy at least 3 months before screening
- Male subjects must agree to not donate sperm from the first dose of study drug through 90 days after the last dose of study drug.
- Subject is considered by the investigator to be in good general health as determined by medical history (no hospitalizations for chronic medical conditions in the previous 2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.
- Subject agrees to comply with all protocol requirements.
- Subject is able to provide written informed consent.
- Subject agrees to comply with the dietary requirements.
- Subject does not intend to lose
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
- Subject has a history of any clinically significant conditions including:
- Asthma treated with oral systemic steroids within the past 6 months
- Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
- Thyroidectomy or thyroid disease that required medication within the past 12 months
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- Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years
- Head trauma resulting in a diagnosis of traumatic brain injury other than concussion
- Frequent episodes of headache.
- Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- Subject has been previously enrolled in any clinical study involving TPOXX (tecovirimat).
- Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or excipients, or any significant food allergy that could preclude a standard diet in the study site).
- Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).
- Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor.
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- Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
- Subject has a family history of sudden cardiac death, not clearly due to acute myocardial infarction.
- Subject has a seizure disorder or history of seizures (does not include childhood febrile seizures) or a past history that increases seizure risks such as significant head injury that caused loss of consciousness or other changes in the subject's daily function, concussion, stroke, central nervous system infection or disease, or alcohol or drug abuse or family history of idiopathic seizures.
- Subject has a history of a peptic ulcer or significant gastrointestinal bleed.
- Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- Subject has a malignancy that is active, or treated malignancy for which there is not reasonable assurance of sustained cure, or malignancy that is likely to recur during the period of the study (subject should be in complete remission for at least 5 years).
- Subject has neutropenia or other blood dyscrasia determined to be clinically significant by the investigator.
- Subject has used any of the following prohibited medications from within 7 days (or 5 half-lives, whichever is longer) before the first dose of study drug: antidiabetic medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4 substrates may be allowed at the investigator's discretion, after consultation with the medical monitor, if administration poses little to no risk to the subject.
- Subject has a history of drug or alcohol abuse or dependency within the last year before screening.
- Subject has a history of an eating disorder.
- Subject has a current or recent (<30 days before screening) history of clinically significant bacterial, fungal, or mycobacterial infection.
- Subject has a current clinically significant viral infection.
- Subject has a known clinically significant chronic viral infection (eg, human T cell lymphotropic virus I or II).
- Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug or throughout the study.
- Subject has used any prescription (excluding hormonal birth control) or over-the-counter medication (including herbal or nutritional supplements) within 14 days before the first dose of study drug.
- Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
- Subject has donated >450 mL blood or blood components within 30 days before the first dose of study drug. The investigator should instruct subjects who participate in this study to not donate blood or blood components for 4 weeks after the completion of the study.
- Subject is a smoker or has used nicotine or nicotine-containing products (eg, cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) within 6 months before the first dose of study drug.
- Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice, or alcohol within 72 hours before the first dose of study drug.
- Subject reports participation in strenuous activity or contact sports within 24 hours before the first dose of study drug.
- Subject has known hepatitis B or C infection or positive test for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies at screening.
- Subject has a positive test result for amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine, and oxycodone), or alcohol at screening or check-in.
- Subject has any of the following laboratory test results within 28 days before the first dose of study drug:
- Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min
- Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper central laboratory reference range)
- Hemoglobin ≤10% of the lower central laboratory reference range
- White blood cell count not within the central laboratory reference range
- Absolute neutrophil count <1000 cells/mm3
- Platelets not within ±10% of central laboratory reference range
- Alanine aminotransferase >1.5 times above the upper central laboratory reference range
- Aspartate aminotransferase >1.5 times above the upper central laboratory reference range
- Alkaline phosphatase >20% above the upper central laboratory reference range
- Hemoglobin A1c ≥7.0%
- Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
- Subject has a blood pressure considered to be clinically significant by the investigator. Blood pressure may be retested twice in the sitting position at 5-minute intervals.
- Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at screening.
- Subject has an abnormal ECG at screening that is determined by the investigator to be clinically significant.
- Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at screening or Day -1.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of TPOXX In Adult Subjects Weighing More Than 120 KG
Safety and PK study in adults weighing more than 120 kg
Read the detailed description
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed in these patients.
Secondary:
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg.
- Conditions
- Smallpox
- Being tested
- Tpoxx
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TpoxxDrug
oral antiviral
| Study group | Role | What they receive |
|---|---|---|
| TPOXX | Other | TPOXX 600 mg BID x 7 days Receives: Drug: Tpoxx |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the plasma concentration vs. time curve (AUC) from time 0 to the last quantifiable measurement following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
Measured: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
AUC0-24
Area under the plasma concentration vs. time curve (AUC) from time 0 to the 24-hour time-point following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7).
Measured: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7)
AUC0-inf
AUC from time 0 extrapolated to infinity
Measured: Day 7
Cmax
Maximum observed plasma drug concentration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7). The median time to achieve Cmax was 4 hours post-dose.
Measured: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
Tmax
Time to reach Cmax
Measured: Day 7
t1/2
Terminal elimination half-life
Measured: Day 7
CL/F
Apparent total body clearance
Measured: Day 7
Vd/F
Apparent volume of distribution
Measured: Day 7
Ctrough
Concentration observed prior to the next dose administration
Measured: Day 7
Secondary outcomes (16)
AEs as Assessed by CTCAE
Number of subjects with AEs as assessed by CTCAE
Measured: 30 days
Subjects With at Least 1 AEs
Number of subjects reported at least 1 adverse event
Measured: 30 days
Average Hemoglobin Concentration at Various Time Points; Mean (Standard Deviation)
Table 14.3.2.1.1Summary of Actual Value and Change from Baseline in Hematology Safety Population Summary tables of observed values and changes from baseline: for hematology laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit..
Central laboratory reference ranges used for all clinical laboratory safety parameters
Measured: Baseline prior to dosing, 3 days post dose, 7 days post dose and 8 days post dose
Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)
Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline.
Central laboratory reference ranges used for all clinical laboratory safety parameters
Measured: Average Serum Chemistry at Baseline, 3 days post dose, 7 days post dose, and 8 days post dose
Average Urinalysis pH Values at Various Time Points:Day 9; Mean (Standard Deviation)
Table 14.3.2.3.2 Laboratory Results - Urinalysis Safety Population Urinalysis laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit.
Central laboratory reference ranges used for all clinical laboratory safety parameters.
Measured: 8 days post dose
Average Systolic and Diastolic Blood Pressures at 9 Day Time Point; Mean (Standard Deviation)
Table 14.3.3.1.1 Vital Sign Results Safety Population
Data listed shows the mean and standard deviation of systolic and diastolic blood pressure of 34 participants on day 9.
Measured: 9 days
Average Heart Rate at 9 Day Time Point; Mean (Standard Deviation)
Table 14.3.3.1.1 Vital Sign Results Safety Population
Data listed shows the mean and standard deviation of heart rate of 34 participants on day 9.
Measured: 9 days
Average Respiratory Rate at 9 Day Time Point; Mean (Standard Deviation)
Table 14.3.3.1.1 Vital Sign Results Safety Population
Data listed shows the mean and standard deviation of respiratory rates for 34 participants on day 9.
Measured: 9 days
Average Body Temperature at 9 Day Time Point; Mean (Standard Deviation)
Table 14.3.3.1.1 Vital Sign Results Safety Population
Data listed shows the mean and standard deviation of body temperatures for 34 participants on day 9.
Measured: 9 days
Average 12-lead ECG at 9 Day Time Point; Mean (Standard Deviation)
Table 14.3.4.1.1 Electrocardiogram Results Safety Population Data listed shows the mean and standard deviation of 12 Lead EKG results for 34 participants on day 9.
Measured: 9 days
Physical Examination at Baseline Compared to Physical Examination 9 Days Post Dose
Listing 16.2.8.8 Physical Exam Safety Population
Subjects were collated based on review of system and classified by assessment as "normal", "abnormal" or "assessments not done" on day 9.
Measured: 9 days
Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Various Time Points Mean (Standard Deviation)
Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline.
Central laboratory reference ranges used for all clinical laboratory safety parameters
Measured: Day 1 pre dose, 3 days, 7 days, and 8 days post dose
Albumin, Globulin, and Protein at Various Time Points Mean (Standard Deviation)
Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline.
Central laboratory reference ranges used for all clinical laboratory safety parameters
Measured: Day 1 pre dose, 3 days post dose, 7 days post dose and 8 days post dose
Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)
Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline.
Central laboratory reference ranges used for all clinical laboratory safety parameters
Measured: Day 1 pre dose, 3, 7, and 8 days post dose
Urobilinogen (Umol/dl) 8 Days Post Dose (Day 9); Mean (Standard Deviation)
Table 14.3.2.3.2 Laboratory Results - Urinalysis Safety Population Summary tables of observed values and changes from baseline: for urinalysis laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit.
Central laboratory reference ranges used for all clinical laboratory safety parameters.
Measured: 8 days post dose
12-lead ECG Heart Rate at 9 Day Time Point; Mean (Standard Deviation)
Table 14.3.4.1.1 Electrocardiogram Results Safety Population Data listed shows the mean and standard deviation of 12 Lead EKG heart rate for 34 participants on day 9.
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start19 Jul 2019
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIGA Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Dennis Hruby, PhD, Study director, SIGA Chief Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392739
- Sponsor's protocol ID
- SIGA-246-022
- Other IDs
- HHSO100201800019C
- Status last verified
- Aug 2024
- First submitted
- 6 May 2020
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of TPOXX In Adult Subjects Weighing More Than 120 KG
- ClinicalTrials.gov ID
- NCT04392739
- Acronym / sponsor ID
- SIGA-246-022
- Conditions
- Smallpox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SIGA TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, PPD Development, LP
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and PK study in adults weighing more than 120 kg
Detailed description
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed in these patients.
Secondary:
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPOXX | Other | Drug: TpoxxTPOXX 600 mg BID x 7 days |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Subject is male or female between 18 and 50 years of age, inclusive.
- Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to dosing on Day 1.
- Women of childbearing potential, have a negative β human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 before receipt of study drug, and meet 1 of the following criteria:
- Male subjects must agree to not donate sperm from the first dose of study drug through 90 days after the last dose of study drug.
- Subject is considered by the investigator to be in good general health as determined by medical history (no hospitalizations for chronic medical conditions in the previous 2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.
Key exclusion criteria (54 listed)
- Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
- Subject has a history of any clinically significant conditions including:
- Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- Subject has been previously enrolled in any clinical study involving TPOXX (tecovirimat).
- Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or excipients, or any significant food allergy that could preclude a standard diet in the study site).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tpoxxoral antiviral | Drug | TPOXX |
Primary outcome
AUC0-t
Time frame: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
Area under the plasma concentration vs. time curve (AUC) from time 0 to the last quantifiable measurement following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
AUC0-24
Time frame: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7)
Area under the plasma concentration vs. time curve (AUC) from time 0 to the 24-hour time-point following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7).
AUC0-inf
Time frame: Day 7
AUC from time 0 extrapolated to infinity
Cmax
Time frame: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
Maximum observed plasma drug concentration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7). The median time to achieve Cmax was 4 hours post-dose.
Tmax
Time frame: Day 7
Time to reach Cmax
t1/2
Time frame: Day 7
Terminal elimination half-life
CL/F
Time frame: Day 7
Apparent total body clearance
Vd/F
Time frame: Day 7
Apparent volume of distribution
Ctrough
Time frame: Day 7
Concentration observed prior to the next dose administration
16 secondary outcomes
AEs as Assessed by CTCAE
Time frame: 30 days
Subjects With at Least 1 AEs
Time frame: 30 days
Average Hemoglobin Concentration at Various Time Points; Mean (Standard Deviation)
Time frame: Baseline prior to dosing, 3 days post dose, 7 days post dose and 8 days post dose
Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)
Time frame: Average Serum Chemistry at Baseline, 3 days post dose, 7 days post dose, and 8 days post dose
Average Urinalysis pH Values at Various Time Points:Day 9; Mean (Standard Deviation)
Time frame: 8 days post dose
Average Systolic and Diastolic Blood Pressures at 9 Day Time Point; Mean (Standard Deviation)
Time frame: 9 days
Average Heart Rate at 9 Day Time Point; Mean (Standard Deviation)
Time frame: 9 days
Average Respiratory Rate at 9 Day Time Point; Mean (Standard Deviation)
Time frame: 9 days
Average Body Temperature at 9 Day Time Point; Mean (Standard Deviation)
Time frame: 9 days
Average 12-lead ECG at 9 Day Time Point; Mean (Standard Deviation)
Time frame: 9 days
Physical Examination at Baseline Compared to Physical Examination 9 Days Post Dose
Time frame: 9 days
Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Various Time Points Mean (Standard Deviation)
Time frame: Day 1 pre dose, 3 days, 7 days, and 8 days post dose
Albumin, Globulin, and Protein at Various Time Points Mean (Standard Deviation)
Time frame: Day 1 pre dose, 3 days post dose, 7 days post dose and 8 days post dose
Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)
Time frame: Day 1 pre dose, 3, 7, and 8 days post dose
Urobilinogen (Umol/dl) 8 Days Post Dose (Day 9); Mean (Standard Deviation)
Time frame: 8 days post dose
12-lead ECG Heart Rate at 9 Day Time Point; Mean (Standard Deviation)
Time frame: 9 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Hruby, PhD study director
SIGA Chief Scientific Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tpoxx in people with Smallpox, run by SIGA Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.