Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
| PPD Development, LP | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Safety and PK study in adults weighing more than 120 kg
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPOXX | Other | TPOXX 600 mg BID x 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tpoxx | Drug | oral antiviral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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 | 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. | 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 | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs as Assessed by CTCAE | Number of subjects with AEs as assessed by CTCAE | 30 days |
| Subjects With at Least 1 AEs | Number of subjects reported at least 1 adverse event |
Not provided
Inclusion Criteria:
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:
i. 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.
ii. Diaphragm or cervical cap with spermicide
iii. Intrauterine device with spermicide
iv. Oral contraceptives or other hormonal methods NOTE: Subject must agree to use an additional nonhormonal method of contraception in conjunction with oral contraceptives.
v. 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
Exclusion Criteria:
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:
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.
Page 10
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dennis Hruby, PhD | SIGA Chief Scientific Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TPOXX | TPOXX 600 mg BID x 7 days Tpoxx: oral antiviral |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TPOXX | TPOXX 600 mg BID x 7 days Tpoxx: oral antiviral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | PK population | Posted | Mean | Standard Error | ng*h/mL | 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). |
|
Adverse events were collected from first dose of study drug until study Day 37 (+2 days).
An AE is any event or any untoward medical occurrence, including those AEs that result from dosing error, which may present during administration of a study drug, or during a reasonable follow-up period, and which does not necessarily have a causal relationship with this treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TPOXX | TPOXX 600 mg BID x 7 days Tpoxx: oral antiviral | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MeDRA 22.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Blum, Assoc. Director of Clinical Research | SIGA Technologies | 541-224-1305 | eblum@siga.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2019 | May 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2020 | May 10, 2021 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012899 | Smallpox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C505045 | tecovirimat |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| t1/2 | Terminal elimination half-life | Day 7 |
| CL/F | Apparent total body clearance | Day 7 |
| Vd/F | Apparent volume of distribution | Day 7 |
| Ctrough | Concentration observed prior to the next dose administration | Day 7 |
| 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 9 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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). | PK population | Posted | Mean | Standard Error | ng*h/mL | 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) |
|
|
|
| Primary | AUC0-inf | AUC from time 0 extrapolated to infinity | PK population | Posted | Mean | Standard Error | ng*h/mL | Day 7 |
|
|
|
| Primary | 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. | PK population | Posted | Mean | Standard Error | ng/mL | 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). |
|
|
|
| Primary | Tmax | Time to reach Cmax | PK population | Posted | Median | Full Range | h | Day 7 |
|
|
|
| Primary | t1/2 | Terminal elimination half-life | PK population | Posted | Mean | Standard Error | h | Day 7 |
|
|
|
| Primary | CL/F | Apparent total body clearance | PK population | Posted | Mean | Standard Error | L/h | Day 7 |
|
|
|
| Primary | Vd/F | Apparent volume of distribution | PK population | Posted | Mean | Standard Error | L | Day 7 |
|
|
|
| Primary | Ctrough | Concentration observed prior to the next dose administration | PK population | Posted | Mean | Standard Error | ng/mL | Day 7 |
|
|
|
| Secondary | AEs as Assessed by CTCAE | Number of subjects with AEs as assessed by CTCAE | Safety population | Posted | Number | participants | 30 days |
|
|
|
| Secondary | Subjects With at Least 1 AEs | Number of subjects reported at least 1 adverse event | Safety population | Posted | Number | participants | 30 days |
|
|
|
| Secondary | 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 | All subjects which were included in the safety population which is defined as all subjects who received at least one dose of TPOXX were included in this analysis. | Posted | Mean | Standard Deviation | Hemoglobin (g/L) | Baseline prior to dosing, 3 days post dose, 7 days post dose and 8 days post dose |
|
|
|
| Secondary | 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 | All subjects which were included in the safety population which is defined as all subjects who received at least one dose of TPOXX were included in this analysis. | Posted | Mean | Standard Deviation | umol/L | Average Serum Chemistry at Baseline, 3 days post dose, 7 days post dose, and 8 days post dose |
|
|
|
| Secondary | 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. | All subjects which were included in the safety population which is defined as all subjects who received at least one dose of TPOXX were included in this analysis. | Posted | Mean | Standard Deviation | pH | 8 days post dose |
|
|
|
| Secondary | 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. | vital sign measurements values | Posted | Mean | Standard Deviation | mmHg | 9 days |
|
|
|
| Secondary | 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. | Mean Heart Rate after dosing. | Posted | Mean | Standard Deviation | beats per minute | 9 days |
|
|
|
| Secondary | 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. | Mean Respiratory Rate after dosing. | Posted | Mean | Standard Deviation | breaths per minute | 9 days |
|
|
|
| Secondary | 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. | Mean Body Temperature after dosing. | Posted | Mean | Standard Deviation | Celsius | 9 days |
|
|
|
| Secondary | 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. | Mean 12-lead ECG values after dosing. | Posted | Mean | Standard Deviation | msec | 9 days |
|
|
|
| Secondary | 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. | Vital sign measurements, physical examination findings, and 12-lead ECG values after dosing. | Posted | Count of Participants | Participants | 9 days |
|
|
|
| Secondary | 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 | All subjects which were included in the safety population which is defined as all subjects who received at least one dose of TPOXX were included in this analysis. | Posted | Mean | Standard Deviation | IU/L | Day 1 pre dose, 3 days, 7 days, and 8 days post dose |
|
|
|
| Secondary | 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 | All subjects which were included in the safety population which is defined as all subjects who received at least one dose of TPOXX were included in this analysis. | Posted | Mean | Standard Deviation | g/L | Day 1 pre dose, 3 days post dose, 7 days post dose and 8 days post dose |
|
|
|
| Secondary | 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 | All subjects which were included in the safety population which is defined as all subjects who received at least one dose of TPOXX were included in this analysis. | Posted | Mean | Standard Deviation | mmol/L | Day 1 pre dose, 3, 7, and 8 days post dose |
|
|
|
| Secondary | 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. | All subjects which were included in the safety population which is defined as all subjects who received at least one dose of TPOXX were included in this analysis. | Posted | Mean | Standard Deviation | umol/dl | 8 days post dose |
|
|
|
| Secondary | 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. | Mean 12-lead ECG values after dosing. | Posted | Mean | Standard Deviation | bats per minute | 9 days |
|
|
|
| 34 |
| 0 |
| 34 |
| 12 |
| 34 |
| Nausea | Gastrointestinal disorders | MeDRA 22.0 | Systematic Assessment |
|
| Infrequent bowel movements | Gastrointestinal disorders | MeDRA 22.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MeDRA 22.0 | Systematic Assessment |
|
| Scleral hyperaemia | Eye disorders | MeDRA 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MeDRA 22.0 | Systematic Assessment |
|
| Palate injury | Injury, poisoning and procedural complications | MeDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MeDRA 22.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MeDRA 22.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MeDRA 22.0 | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|---|
|
| 8 days post dose (Day 9) |
|
|
| Urate (umol/L) 3 days post dose (Day 4) |
|
| Urate (umol/L) 7 days post dose (Day 8) |
|
| Urate (umol/L) 8 days post dose (Day 9) |
|
| Title | Measurements |
|---|---|
|
| 8 days post dose (Day 9) Normal: HEENT |
|
| 8 days post dose (Day 9) Abnormal: HEENT |
|
| 8 days post dose (Day 9) HEENT: Not Done |
|
| 8 days post dose (Day 9) Normal: Pulmonary |
|
| 8 days post dose (Day 9) Abnormal: Pulmonary |
|
| 8 days post dose (Day 9) Not Done: Pulmonary |
|
| 8 days post dose (Day 9) Normal: Cardiovascular |
|
| 8 days post dose (Day 9) Abnormal: Cardiovascular |
|
| 8 days post dose (Day 9) Not done: Cardiovascular |
|
| 8 days post dose (Day 9) Abdomen: Normal |
|
| 8 days post dose (Day 9) Abnormal: Abdomen |
|
| 8 days post dose (Day 9) Not Done: Abdomen |
|
| 8 days post dose (Day 9) Normal: Lymph Nodes |
|
| 8 days post dose (Day 9) Abnormal: Lymph Nodes |
|
| 8 days post dose (Day 9) Not Done: Lymph Nodes |
|
| 8 days post dose (Day 9) Normal: Musculoskeletal |
|
| 8 days post dose (Day 9) Abnormal: Musculoskeletal |
|
| 8 days post dose (Day 9) Not Done: Musculoskeletal |
|
| 8 days post dose (Day 9) Normal: Neurological System |
|
| 8 days post dose (Day 9) Abnormal: Neurological System |
|
| 8 days post dose (Day 9) Not Done: Neurological System |
|
| 8 days post dose (Day 9) Normal: Other |
|
| 8 days post dose (Day 9) Abnormal: Other |
|
| 8 days post dose (Day 9) Not Done: Other |
|
|
| Alanine Aminotransferase (I/UL) 8 days post dose (Day 9) |
|
| Alk Phosphate (IU/L) Baseline |
|
| Alk Phosphate (IU/L)3 days post dose (Day 4) |
|
| Alk Phosphate (IU/L) 7 days post dose (Day 8) |
|
| Alk Phosphate (IU/L) 8 days post dose (Day 9) |
|
| Aspartate Aminotransferase (IU/L) Baseline |
|
| Aspartate Aminotransferase (IU/L) 3 days post dose (Day 4) |
|
| Aspartate Aminotransferase (IU/L) 7 days post dose (Day 8) |
|
| Aspartate Aminotransferase (IU/L) 8 days post dose (Day 9) |
|
| Gamma Glutamyl Transferase (IU/L) Baseline |
|
| Gamma Glutamyl Transferase (IU/L) 3 days post dose (Day 4) |
|
| Gamma Glutamyl Transferase (IU/L) 7 days post dose (Day 8) |
|
| Gamma Glutamyl Transferase (IU/L) 8 days post dose (Day 9) |
|
| Lactate Dehydrogenase (IU/L) Baseline |
|
| Lactate Dehydrogenase (IU/L) 3 days post dose (Day 4) |
|
| Lactate Dehydrogenase (IU/L) 7 days post dose (Day 8) |
|
| Lactate Dehydrogenase (IU/L) 8 days post dose (Day 9) |
|
|
| Albumin (g/L)8 days post dose (Day 9) |
|
| Globulin (g/L) Baseline |
|
| Globulin (g/L) 3 days post dose (Day 4) |
|
| Globulin (g/L) 7 days post dose (Day 8) |
|
| Globulin (g/L) 8 days post dose (Day 9) |
|
| Protein (g/L) Baseline |
|
| Protein (g/L) 3 days post dose (Day 4) |
|
| Protein (g/L) 7 days post dose (Day 8) |
|
| Protein (g/L) 8 days post dose (Day 9) |
|
|
| Anion Gap (mmol/L) 8 days post dose (Day 9) |
|
| Blood Urea Nitrogen (mmol/L) Baseline |
|
| Blood Urea Nitrogen (mmol/L) 3 days post dose (Day 4) |
|
| Blood Urea Nitrogen (mmol/L) 7 days post dose (Day 8) |
|
| Blood Urea Nitrogen (mmol/L) 8 days post dose (Day 9) |
|
| Calcium (mmol/L) Baseline |
|
| Calcium (mmol/L) 3 days post dose (Day 4) |
|
| Calcium (mmol/L) 7 days post dose (Day 8) |
|
| Calcium (mmol/L) 8 days post dose (Day 9) |
|
| Carbon Dioxide (mmol/L) Baseline |
|
| Carbon Dioxide (mmol/L) 3 days post dose (Day 4) |
|
| Carbon Dioxide (mmol/L) 7 days post dose (Day 8) |
|
| Carbon Dioxide (mmol/L) 8 days post dose (Day 9) |
|
| Chloride (mmol/L) Baseline |
|
| Chloride (mmol/L) 3 days post dose (Day 4) |
|
| Chloride (mmol/L) 7 days post dose (Day 8) |
|
| Chloride (mmol/L) 8 days post dose (Day 9) |
|
| Glucose (mmol/L) Baseline |
|
| Glucose (mmol/L) 3 days post dose (Day 4) |
|
| Glucose (mmol/L) 7 days post dose (Day 8) |
|
| Glucose (mmol/L) 8 days post dose (Day 9) |
|
| Phosphate (mmol/L) Baseline |
|
| Phosphate (mmol/L) 3 days post dose (Day 4) |
|
| Phosphate (mmol/L) 7 days post dose (Day 8) |
|
| Phosphate (mmol/L) 8 days post dose (Day 9) |
|
| Potassium (mmol/L) Baseline |
|
| Potassium (mmol/L) 3 days post dose (Day 4) |
|
| Potassium (mmol/L) 7 days post dose (Day 8) |
|
| Potassium (mmol/L) 8 days post dose (Day 9) |
|
| Sodium (mmol/L) Baseline |
|
| Sodium (mmol/L) 3 days post dose (Day 4) |
|
| Sodium (mmol/L) 7 days post dose (Day 8) |
|
| Sodium (mmol/L) 8 days post dose (Day 9) |
|