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

Last updated: May 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

EYU688

Placebo

Clinical Study ID

NCT06006559
CEYU688A12201
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, 18 - 60 years old (inclusive).

  • History or presence of fever (≥ 38°C). At least one of the following criteriaindicating 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

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 considersshould exclude the participants, especially those that require continuation of othermedications 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

  1. at screening.
  • Participants with any of the following abnormalities of clinical laboratoryparameters 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 tostomach pH value increase up to 48 hours prior to screening.

  • Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring dosing and for 4 days after stopping of investigational drug.

  • History or long-QT syndrome, or clinically significant ECG abnormalities, or any ofthe following ECG abnormalities at screening:

  • QTcF > 450 msec (males)

  • QTcF > 460 msec (females)

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: EYU688
Phase: 2
Study Start date:
February 20, 2024
Estimated Completion Date:
February 27, 2026

Study 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]).

Connect with a study center

  • Novartis Investigative Site

    Manaus, AM 69040-000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Brasilia, DF 71 635-580
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sorocaba, SP 18040-425
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Mumbai, Maharashtra 400008
    India

    Active - Recruiting

  • Novartis Investigative Site

    Pune, Maharashtra 411013
    India

    Active - Recruiting

  • Novartis Investigative Site

    Jaipur, Rajasthan 302017
    India

    Active - Recruiting

  • Novartis Investigative Site

    Chennai, Tamilnadu 600113
    India

    Active - Recruiting

  • Novartis Investigative Site

    Kuantan, Pahang 25200
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Ipoh, Perak 30450
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Seberang Jaya, Pulau Pinang 13700
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Miri, Sarawak 98000
    Malaysia

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, S308433
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Hanoi, 100000
    Vietnam

    Active - Recruiting

  • Novartis Investigative Site

    Ho Chi Minh, 700000
    Vietnam

    Active - Recruiting

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