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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Dengue

In brief

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.

Key facts

Study ID

NCT06006559

Run by

Novartis Pharmaceuticals

People needed

108

Starts

2024-02-20

Expected to finish

2027-07-30

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Ho Chi Minh City, Vietnam (enrolling)
• Novartis Investigative Site — Brasília, Federal District, Brazil (enrolling)
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
• Novartis Investigative Site — Rio Grande, Rio Grande do Sul, Brazil (enrolling)
• Novartis Investigative Site — Sorocaba, São Paulo, Brazil (enrolling)
• Novartis Investigative Site — Sao Jose Rio Preto, Brazil (enrolling)
• Novartis Investigative Site — Haiphong, Vietnam (enrolling)
• Novartis Investigative Site — Hanoi, Vietnam (enrolling)
• Novartis Investigative Site — Manaus, Amazonas, Brazil (enrolling)
• Novartis Investigative Site — Cali, Valle del Cauca Department, Colombia (enrolling)
• Novartis Investigative Site — Belagavi, Karnataka, India (enrolling)
• Novartis Investigative Site — Pune, Maharashtra, India (enrolling)
• Novartis Investigative Site — Jaipur, Rajasthan, India (enrolling)
• Novartis Investigative Site — Chennai, Tamil Nadu, India (enrolling)
• Novartis Investigative Site — Kuantan, Pahang, Malaysia (enrolling)
• Novartis Investigative Site — Ipoh, Perak, Malaysia (enrolling)
• Novartis Investigative Site — Seberang Jaya, Pulau Pinang, Malaysia (enrolling)
• Novartis Investigative Site — Miri, Sarawak, Malaysia (enrolling)
• Novartis Investigative Site — Kuala Selangor, Malaysia (enrolling)
• Novartis Investigative Site — Singapore, Singapore, Singapore (enrolling)
• Novartis Investigative Site — Singapore, Singapore (enrolling)
• Novartis Investigative Site — Barranquilla, Atlántico, Colombia
• Novartis Investigative Site — Bucaramanga, Santander Department, Colombia
• Novartis Investigative Site — Mumbai, Maharashtra, India

Full record on ClinicalTrials.gov

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