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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 60 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

108 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (27)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

27 locations

Study team and timeline

Lead sponsor

Novartis Pharmaceuticals

Study start

Feb 20, 2024 Actual

Primary completion

Jul 22, 2027 Estimated

Study completion

Jul 30, 2027 Estimated

First posted

Aug 23, 2023 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts