This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza

Phase 2Active Not RecruitingNCT07371650

Traws Pharma, Inc.105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Influenza

Interventions

TRX-100DRUG

CEN inhibitor, dosage form - capsules, dosing regimen - QD

Standard of Care (SOC)DRUG

Standard of Care Influenza Antiviral therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novatrials

Charlestown, New South Wales, Australia

Outcomes

Primary Outcomes

Incidence of AE/SAE

Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)

Time frame: up to Day 28

Incidence of abnormal laboratory tests results

Number of participants with abnormal laboratory tests results

Time frame: Up to Day 28

Incidence of abnormal clinically significant ECG results

Time frame: Up to 28 days

Number of participants with abnormal physical examinations findings

Time frame: Up to 28 days

Secondary Outcomes

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

Time frame: up to Day 15

Plasma Tmax

Time to reach the maximum plasma concentration of TRX-100.

Time frame: PK samples will be collected from Day 1 through Day 22.

Incidence of influenza-related complications

Time frame: 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)

Time frame: Up to 28 days

Time to resolution of fever to <37 C (axillary temperature)

Data from ClinicalTrials.gov

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Time frame: Up to 28 days

Percentage of participants with resolution of fever

Time frame: Up to 28 days

Time needed to return to pre-influenza health status based on assessment of activities score

Time frame: Up to 28 Days

Plasma Cmax

TRX-100 peak plasma concentration

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-100

Time frame: PK samples will be collected from Day 1 through Day 22.

Plasma Cmax

TRX-101 peak plasma concentration

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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: 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.

Time frame: PK samples will be collected from Day 1 through Day 22.