Influenza
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTRX-100
CEN inhibitor, dosage form - capsules, dosing regimen - QD
DRUGStandard of Care (SOC)
Standard of Care Influenza Antiviral therapy
Sponsors
Traws Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Participants with a diagnosis of influenza A or B virus infection * The time interval between the onset of symptoms and enrollment is 48 hours or less * Satisfactory baseline medical assessment by history and physical examination
Exclusion criteria
* Positive test results for SARS-CoV-2 infection and/or respiratory syncytial virus infection * Participants with concurrent infections requiring systemic antimicrobial therapy * Participants with any serious or chronic underlying disease likely to affect study outcomes at the Investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AE/SAE | up to Day 28 | Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs) |
| Incidence of abnormal laboratory tests results | Up to Day 28 | Number of participants with abnormal laboratory tests results |
| Incidence of abnormal clinically significant ECG results | Up to 28 days | — |
| Number of participants with abnormal physical examinations findings | Up to 28 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the total score of 7 influenza symptoms | up to Day 15 | 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 |
| Plasma Tmax | PK samples will be collected from Day 1 through Day 22. | Time to reach the maximum plasma concentration of TRX-100. |
| 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 | PK samples will be collected from Day 1 through Day 22. | TRX-100 peak plasma concentration |
| 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. | — |
| 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) | 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 for TRX-100. |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity | PK samples will be collected from Day 1 through Day 22. | A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-100. |
| Area under the concentration-time curve extrapolated to infinity | PK samples will be collected from Day 1 through Day 22. | A measure of total drug exposure from administration extrapolated to infinite time, estimated for TRX-101. |
| Terminal elimination half-life | PK samples will be collected from Day 1 through Day 22. | The time required for the plasma concentration of TRX-100 to decrease by 50% in the terminal elimination phase. |
| Terminal elimination rate constant | PK samples will be collected from Day 1 through Day 22 | The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-100. |
| Terminal elimination rate constant. | PK samples will be collected from Day 1 through Day 22 | The first-order rate constant associated with the terminal elimination phase of the plasma concentration-time curve for TRX-101. |
| Apparent oral clearance (CL/F) | PK samples will be collected from Day 1 through Day 22 | Apparent total clearance of TRX-100 from plasma following oral administration |
| Apparent volume of distribution during the terminal phase | PK samples will be collected from Day 1 through Day 22. | 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. |
| 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. | — |
Countries
Australia
Outcome results
None listed