Status:
RECRUITING
A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Dengue
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 patie...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 7 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06006559
Start Date
February 20 2024
End Date
September 7 2026
Last Update
November 25 2025
Active Locations (23)
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1
Novartis Investigative Site
Manaus, Amazonas, Brazil, 69040-000
2
Novartis Investigative Site
Brasília, Federal District, Brazil, 71 635-580
3
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
4
Novartis Investigative Site
Sorocaba, São Paulo, Brazil, 18040-425