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

March 23, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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]).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Brazil
      • Sao Jose Rio Preto, Brazil, 15090 000
        • Recruiting
        • Novartis Investigative Site
    • Amazonas
      • Manaus, Amazonas, Brazil, 69040-000
        • Recruiting
        • Novartis Investigative Site
    • Federal District
      • Brasília, Federal District, Brazil, 71635-580
        • Recruiting
        • Novartis Investigative Site
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
        • Recruiting
        • Novartis Investigative Site
    • São Paulo
      • Sorocaba, São Paulo, Brazil, 18040-425
        • Recruiting
        • Novartis Investigative Site
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080012
        • Recruiting
        • Novartis Investigative Site
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 681017
        • Recruiting
        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Novartis Investigative Site
  • India
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Withdrawn
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411013
        • Recruiting
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Recruiting
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600113
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
      • Kuala Selangor, Malaysia, 68000
        • Recruiting
        • Novartis Investigative Site
    • Pahang
      • Kuantan, Pahang, Malaysia, 25200
        • Recruiting
        • Novartis Investigative Site
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Recruiting
        • Novartis Investigative Site
    • Pulau Pinang
      • Seberang Jaya, Pulau Pinang, Malaysia, 13700
        • Recruiting
        • Novartis Investigative Site
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
        • Recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Recruiting
        • Novartis Investigative Site
      • Singapore, Singapore, S308433
        • Recruiting
        • Novartis Investigative Site
  • Vietnam
      • Haiphong, Vietnam, 180000
        • Recruiting
        • Novartis Investigative Site
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Novartis Investigative Site
      • Ho Chi Minh City, Vietnam, 700000
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 4 days 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo administered orally as capsules
Experimental: EYU688
EYU688 administered by oral route
Drug: EYU688
EYU688 administered by oral route

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start
Time Frame: From predose to 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃
Time Frame: From fever onset to Day 15
Efficacy assessment of EYU688. It will allow to assess the time needed between fever onset and defervescence.
From fever onset to Day 15
Time from fever onset to the first of two consecutive negative viremia by PCR
Time Frame: From fever onset to Day 15
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15
From fever onset to Day 15
Area under the log-transformed viremia curve (AUC) from the first dose to Day 15
Time Frame: From fever onset to Day 15
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day 15
From fever onset to Day 15
Changes of viral load over time
Time Frame: From baseline to Day 15
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15
From baseline to Day 15
Incidence and severity of Adverse Events (AEs)
Time Frame: From inclusion to Day 15
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
Incidence and severity of Serious Adverse Events (SAEs)
Time Frame: From inclusion to Day 35
Incidence and severity of SAEs by treatment group
From inclusion to Day 35
Change of white blood cell count over time from baseline
Time Frame: From baseline to Day 15
Assessment of safety and tolerability of EYU688
From baseline to Day 15
Change of platelet count over time
Time Frame: From baseline to Day 15
Assessment of safety and tolerability of EYU688
From baseline to Day 15
Change of hematocrit level and percentage increase from baseline over time
Time Frame: From baseline to Day 15
Assessment of safety and tolerability of EYU688
From baseline to Day 15
Change of AST, ALT levels over time
Time Frame: From baseline to Day 15
Assessment of safety and tolerability of EYU688
From baseline to Day 15
No warning signs by day 7 of fever onset
Time Frame: From inclusion to Day 15
Assessment of the dengue fever clinical evolution under EYU688
From inclusion to Day 15
Diagnosis of severe dengue fever
Time Frame: From inclusion to Day 15
Assessment of the dengue fever clinical evolution under EYU688
From inclusion to Day 15
Diagnosis of dengue hemorrhagic fever (DHF)
Time Frame: From inclusion to Day 15
Assessment of the dengue fever clinical evolution under EYU688
From inclusion to Day 15
Plasma leakage
Time Frame: From inclusion to Day 15
Assessment of the dengue fever clinical evolution under EYU688
From inclusion to Day 15
Requiring fluid infusion
Time Frame: From inclusion to Day 15
Assessment of the dengue fever clinical evolution under EYU688
From inclusion to Day 15
Time from fever onset to clinical recovery
Time Frame: From fever onset to Day 15
Assessment of the dengue fever clinical evolution under EYU688
From fever onset to Day 15
PK parameter (Cmax)
Time Frame: From Day 1 to Day 6
Pharmacokinetic assessment of EYU688 in dengue fever patients
From Day 1 to Day 6
PK parameter (Tmax)
Time Frame: From Day 1 to Day 6
Pharmacokinetic assessment of EYU688 in dengue fever patients
From Day 1 to Day 6
PK parameter (partial AUCs)
Time Frame: From Day 1 to Day 6
Pharmacokinetic assessment of EYU688 in dengue fever patients
From Day 1 to Day 6
PK concentrations following multiple doses
Time Frame: From Day 1 to Day 6
Pharmacokinetic assessment of EYU688 in dengue fever patients
From Day 1 to Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEYU688A12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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