A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
NCT ID: NCT06006559
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
108 participants
INTERVENTIONAL
2024-02-20
2026-09-07
Brief Summary
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Detailed Description
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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 \[cohort 2\]).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EYU688
EYU688 administered by oral route
EYU688
EYU688 administered by oral route
Placebo
Matching placebo
Placebo
Matching placebo administered orally as capsules
Interventions
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EYU688
EYU688 administered by oral route
Placebo
Matching placebo administered orally as capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Manaus, Amazonas, Brazil
Novartis Investigative Site
Brasília, Federal District, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative Site
Sorocaba, São Paulo, Brazil
Novartis Investigative Site
Sao Jose Rio Preto, , Brazil
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Bucaramanga, Santander Department, Colombia
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia
Novartis Investigative Site
Belagavi, Karnataka, India
Novartis Investigative Site
Mumbai, Maharashtra, India
Novartis Investigative Site
Pune, Maharashtra, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Chennai, Tamil Nadu, India
Novartis Investigative Site
Kuantan, Pahang, Malaysia
Novartis Investigative Site
Ipoh, Perak, Malaysia
Novartis Investigative Site
Seberang Jaya, Pulau Pinang, Malaysia
Novartis Investigative Site
Miri, Sarawak, Malaysia
Novartis Investigative Site
Kuala Selangor, , Malaysia
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Haiphong, , Vietnam
Novartis Investigative Site
Hanoi, , Vietnam
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CEYU688A12201
Identifier Type: -
Identifier Source: org_study_id
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