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

Launched by NOVARTIS PHARMACEUTICALS · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EYU688 for patients with dengue fever, a viral illness that can cause high fever and other symptoms like headaches, muscle pain, and rash. The goal of the study is to see how well EYU688 works to reduce the amount of the virus in the body and to help patients feel better faster compared to a placebo (a treatment that looks like the real drug but has no active ingredients). Researchers are currently looking for participants aged 18 to 60 who have had a fever of 38°C or higher and show signs of dengue infection within the last two days.

If you or someone you know is interested in participating, it's important to know that there are certain health criteria to meet. For example, participants should not be pregnant, have significant medical conditions, or be taking specific medications that might interfere with the study. During the trial, participants will receive either EYU688 or a placebo, and researchers will monitor their health and symptoms closely. This trial is an opportunity to contribute to finding a potential treatment for dengue fever while receiving medical care and support.

Gender

ALL

Eligibility criteria

• 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 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.