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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06006559
Other study ID # CEYU688A12201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 20, 2024
Est. completion date February 24, 2026

Study information

Verified date June 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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 February 24, 2026
Est. primary completion date January 22, 2026
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.

Study Design


Related Conditions & MeSH terms


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 Maharashtra
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
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