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Clinical Trials in India / NCT06006559
Recruiting Phase 2

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

NCT06006559 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2024-02-20
Last updated
2026-09-15

Condition(s) studied

Dengue

Investigational drug(s) / intervention(s)

EYU688Placebo

EYU688: EYU688 administered by oral route

Placebo: Matching placebo administered orally as capsules

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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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 3 X 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.

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Novartis Investigative Site Manaus Amazonas Recruiting
Novartis Investigative Site Brasília Federal District Recruiting
Novartis Investigative Site Rio de Janeiro Rio de Janeiro Recruiting
Novartis Investigative Site Porto Alegre Rio Grande do Sul Recruiting
Novartis Investigative Site São Caetano do Sul São Paulo Recruiting
Novartis Investigative Site São José do Rio Preto São Paulo Recruiting
Novartis Investigative Site Sorocaba São Paulo Recruiting
Novartis Investigative Site Barranquilla Atlántico Recruiting
Novartis Investigative Site Bucaramanga Santander Department Recruiting
Novartis Investigative Site Cali Valle del Cauca Department Recruiting
Novartis Investigative Site Belagavi Karnataka Recruiting
Novartis Investigative Site Mumbai Maharashtra Withdrawn
Novartis Investigative Site Pune Maharashtra Recruiting
Novartis Investigative Site Jaipur Rajasthan Recruiting
Novartis Investigative Site Chennai Tamil Nadu Recruiting
Novartis Investigative Site Kuantan Pahang Recruiting
Novartis Investigative Site Ipoh Perak Recruiting
Novartis Investigative Site Seberang Jaya Pulau Pinang Recruiting
Novartis Investigative Site Miri Sarawak Recruiting
Novartis Investigative Site Kuala Selangor Malaysia Recruiting
Novartis Investigative Site Oaxaca City Mexico Recruiting
Novartis Investigative Site Veracruz Mexico Recruiting
Novartis Investigative Site Singapore Singapore Recruiting
Novartis Investigative Site Singapore Singapore Recruiting
Novartis Investigative Site Haiphong Vietnam Recruiting
Novartis Investigative Site Hanoi Vietnam Recruiting
Novartis Investigative Site Ho Chi Minh City Vietnam Recruiting

More Novartis Pharmaceuticals trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06006559 on ClinicalTrials.gov ↗ ← All trials in India