Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT06006559
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06006559
Study Brief:
Protocol Section:
NCT06006559