A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

Dengue Clinical Trial

Official title:

A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06006559
• Other study ID #: CEYU688A12201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 20, 2024
• Est. completion date: October 10, 2025

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.

Description:

This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever. Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK [cohort 1] and sparse PK sampling [cohort 2]).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: October 10, 2025
• Est. primary completion date: September 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female, 18 - 60 years old (inclusive).
• History or presence of fever (= 38°C). At least one of the following criteria

indicating dengue infection:

• Nausea or vomiting.
• Presence of rash, aches or pains including headache, muscle or joint pain.
• Onset of fever = 48 hours prior to treatment start.
• Positive test on dengue fever.

Exclusion Criteria:

• Participants with any of abnormalities of clinical laboratory parameters.
• Usage of any anticoagulant drugs.
• Current significant medical conditions or illness that the investigator considers should exclude the participants, especially those that require continuation of other medications likely to have an interaction with the study drug.
• Pregnant or nursing (lactating) women.
• Clinical signs and symptoms for severe dengue according to Dengue Guideline (WHO 2009) at screening.
• Participants with any of the following abnormalities of clinical laboratory parameters

at screening:

• Hemoglobin <12.0 g/dL in males; <11.0 g/dL in females
• Hematocrit >52 % in males; >46 % in females
• Absolute neutrophil count <1500/µL
• Platelet count <80,000/mm3
• Creatinine >165 µmol/L in males; >130 µmol/L in females
• Serum creatine kinase > 600 U/L
• ALT, AST levels more than 1.5X upper limit of normal (ULN)
• Total bilirubin >24 µmol/L
• Usage of PPIs (proton pump inhibitor) which could affect absorption of EYU688 due to stomach pH value increase up to 48 hours prior to screening.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for five half-lives or 4 days whichever is longer after stopping of investigational drug.
• History or long-QT syndrome, or clinically significant ECG abnormalities, or any of

the following ECG abnormalities at screening:

• QTcF > 450 msec (males)
• QTcF > 460 msec (females) Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Dengue

Intervention

Drug:
• EYU688
EYU688 administered by oral route
• Placebo
Matching placebo administered orally as capsules

Locations

Country	Name	City	State
India	Novartis Investigative Site	Chennai	Tamilnadu
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Mumbai
Malaysia	Novartis Investigative Site	Kuantan	Pahang
Malaysia	Novartis Investigative Site	Miri	Sarawak
Malaysia	Novartis Investigative Site	Seberang Jaya	Pulau Pinang
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

India,  Malaysia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start	Efficacy assessment of EYU688. It will allow to quantify the viremia reduction at 48 hours post treatment start from baseline.	From predose to 48 hours post treatment start
Secondary	Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5?	Efficacy assessment of EYU688. It will allow to assess the time needed between fever onset and defervescence.	From fever onset to Day 15
Secondary	Time from fever onset to the first of two consecutive negative viremia by PCR	Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15	From fever onset to Day 15
Secondary	Area under the log-transformed viremia curve (AUC) from the first dose to Day 15	Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day 15	From fever onset to Day 15
Secondary	Changes of viral load over time	Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15	From baseline to Day 15
Secondary	Incidence and severity of Adverse Events (AEs)	Incidence and severity of AEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.	From inclusion to Day 15
Secondary	Incidence and severity of Serious Adverse Events (SAEs)	Incidence and severity of SAEs by treatment group	From inclusion to Day 35
Secondary	Change of white blood cell count over time from baseline	Assessment of safety and tolerability of EYU688	From baseline to Day 15
Secondary	Change of platelet count over time	Assessment of safety and tolerability of EYU688	From baseline to Day 15
Secondary	Change of hematocrit level and percentage increase from baseline over time	Assessment of safety and tolerability of EYU688	From baseline to Day 15
Secondary	Change of AST, ALT levels over time	Assessment of safety and tolerability of EYU688	From baseline to Day 15
Secondary	No warning signs by day 7 of fever onset	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Secondary	Diagnosis of severe dengue fever	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Secondary	Diagnosis of dengue hemorrhagic fever (DHF)	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Secondary	Plasma leakage	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Secondary	Requiring fluid infusion	Assessment of the dengue fever clinical evolution under EYU688	From inclusion to Day 15
Secondary	Time from fever onset to clinical recovery	Assessment of the dengue fever clinical evolution under EYU688	From fever onset to Day 15
Secondary	PK parameter (Cmax)	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6
Secondary	PK parameter (Tmax)	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6
Secondary	PK parameter (partial AUCs)	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6
Secondary	PK concentrations following multiple doses	Pharmacokinetic assessment of EYU688 in dengue fever patients	From Day 1 to Day 6