Assessing the effects of EYU688 on dengue fever

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of EYU688 in treating patients with dengue fever compared to a placebo. It is a randomized, participant- and investigator-blinded, placebo-controlled trial that aims to measure the impact of EYU688 on dengue viral load, fever clearance time, and clinical symptoms. The study includes two cohorts with different pharmacokinetic sampling schedules to gather comprehensive data on the drug's effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Manaus, Amazonas, Brazil Recruiting
• Novartis Investigative Site
  Brasília, Federal District, Brazil Recruiting
• Novartis Investigative Site
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Novartis Investigative Site
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Novartis Investigative Site
  São Caetano do Sul, São Paulo, Brazil Recruiting
• Novartis Investigative Site
  São José do Rio Preto, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.