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This is an early-stage clinical trial to determine a safe and effective dose for Tivoxavir Marboxil (TRX-100) in patients with mild to moderate Influenza. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.
This is a multicenter, open-label, randomized, Phase 2a study to evaluate the safety, tolerability, and pilot efficacy of different oral doses of TRX-100 in otherwise healthy participants with mild to moderate influenza. The study will also evaluate PK of TRX-100 and its major active metabolite, TRX-101, following single oral doses of TRX-100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRX-100 Dose Level 1 | Experimental | Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100. |
|
| TRX-100 Dose Level 2 | Experimental | Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100. |
|
| Standard of Care (SOC) | Active Comparator | Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRX-100 | Drug | CEN inhibitor, dosage form - capsules, dosing regimen - QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AE/SAE | Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs) | up to Day 28 |
| Incidence of abnormal laboratory tests results | Number of participants with abnormal laboratory tests results | Up to Day 28 |
| Incidence of abnormal clinically significant ECG results | Up to 28 days | |
| Number of participants with abnormal physical examinations findings | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the total score of 7 influenza symptoms | Seven symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue) will be assessed by the participant and recorded on a 4-point severity scale | up to Day 15 |
| Plasma Tmax |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Viral Titer | Change of virus titer compared to pretreatment baseline sample | up to Day 6 |
| Change from Baseline in Viral Load | Change in virus load compared to pretreatment baseline sample |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novatrials | Charlestown | New South Wales | 2290 | Australia |
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Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
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| Standard of Care (SOC) | Drug | Standard of Care Influenza Antiviral therapy |
|
Time to reach the maximum plasma concentration of TRX-100. |
| PK samples will be collected from Day 1 through Day 22. |
| Incidence of influenza-related complications | Up to 28 days |
| Time to alleviation of influenza clinical symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, and fatigue) | Up to 28 days |
| Time to resolution of fever to <37 C (axillary temperature) | Up to 28 days |
| Percentage of participants with resolution of fever | Up to 28 days |
| Time needed to return to pre-influenza health status based on assessment of activities score | Up to 28 Days |
| Plasma Cmax | TRX-100 peak plasma concentration | PK samples will be collected from Day 1 through Day 22. |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-100 | PK samples will be collected from Day 1 through Day 22. |
| Plasma Cmax | TRX-101 peak plasma concentration | PK samples will be collected from Day 1 through Day 22. |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101 | PK samples will be collected from Day 1 through Day 22. |
| Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24) | Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-100. | PK samples will be collected from Day 1 through Day 22. |
| Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24) | Area under the plasma concentration-time curve from time zero to 24 hours post-dose for TRX-101. | PK samples will be collected from Day through Day 22 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity | A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-100. | PK samples will be collected from Day 1 through Day 22. |
| Area under the concentration-time curve extrapolated to infinity | A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-101. | PK samples will be collected from Day 1 through Day 22. |
| Terminal elimination half-life | The time required for the plasma concentration of TRX-100 to decrease by 50% in the terminal elimination phase. | PK samples will be collected from Day 1 through Day 22. |
| Terminal elimination half-life | The time required for the plasma concentration of TRX-101 to decrease by 50% in the terminal elimination phase. | PK samples will be collected from Day 1 through Day 22 |
| Terminal elimination rate constant | The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-100. | PK samples will be collected from Day 1 through Day 22 |
| Terminal elimination rate constant. | The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-101. | PK samples will be collected from Day 1 through Day 22 |
| Apparent oral clearance (CL/F) | Apparent total clearance of TRX-100 from plasma following oral administration | PK samples will be collected from Day 1 through Day 22 |
| Apparent oral clearance (CL/F) | Apparent total clearance of TRX-101 from plasma following oral administration | PK samples will be collected from Day 1 through Day 22 |
| Apparent volume of distribution during the terminal phase | Apparent volume of distribution of TRX-100 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant. | PK samples will be collected from Day 1 through Day 22. |
| Apparent volume of distribution during the terminal phase | Apparent volume of distribution of TRX-101 during the terminal elimination phase following oral administration, calculated as Clearance (CL/F) divided by the elimination rate constant. | PK samples will be collected from Day 1 through Day 22. |
| Plasma Tmax | Time to reach the maximum plasma concentration of TRX-101. | Time Frame: PK samples will be collected from Day 1 through Day 22. |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of TRX-101. | PK samples will be collected from Day 1 through Day 22. |
| up to Day 6 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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