Health Condition 1: A90- Dengue fever [classical dengue]
Conditions
Interventions
Intervention1: EYU688: 500 mg -twice daily (q12h) for 5 days
Intervention2: Matching placebo: twice daily (q12h) for 5 days
Control Intervention1: NA: NA
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 - 60 years old (inclusive) 2. History or presence of fever (>= 38°C) (could be based on medical record or measurement of body temperature) coinciding with a clinical suspicion of dengue infection at screening: At least one of the following criteria indicating probable dengue infection: • Nausea or vomiting • Presence of rash, aches or pains including headache retro-orbital, muscle or joint pain. 3. Onset of fever 4. Positive NS1 rapid test or RT-PCR at screening. 5. Able to communicate well with the investigator, to understand and comply with the requirements of the study. 6. Written informed consent must be obtained before any assessment is performed.
Exclusion criteria
Exclusion criteria: Clinical signs and symptoms for severe dengue (listed in Section 8.3.2.3) according to Dengue Guideline (WHO 2009) at screening. Participants with any of the following abnormalties of clinical laboratory parameters at screening: Hemoglobin Hematocrit >52 % in males; >46 % in females Absolute neutrophil count Platelet count 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 any anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel at screening. 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. 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) Current significant medical conditions or illness including cardiac arrhythmia, cardiomyopathy or other cardiac disease, asthma, or other respiratory disease, diabetes mellitus, renal or hepatic impairment, thyroid disease, Parkinsonâ??s disease, epilepsy or history of unexplained blackouts, immunocompromised state including known HIV infection, or any other 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 at 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 five half-lives or 4 days whichever is longer after stopping of investigational drug. Signs or symptoms, in the judgment of the investigator, of a clinically significant systemic viral, bacterial, parasitological, or fungal infection within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of EYU688 compared to placebo with respect to change on viral loadTimepoint: Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the efficacy of EYU688 compared to placebo with respect to fever clearance time (FCT)Timepoint: Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5°C. Endpints taken on every treatment visit;To determine the efficacy of EYU688 compared to placebo with respect to viremia kineticsTimepoint: Time from fever onset to the first of two consecutive negative viremia by PCR Area under the log-transformed viremia curve (AUC) from the first dose to Day 15 Changes of viral load over time ;To assess the safety & tolerability of EYU688Timepoint: Occurrence of treatment emergent AE, SAE, vital signs, ECG & safety laboratory abnormalities taken through out the study;To assess the pharmacokinetics profile of EYU688 in participants with dengue feverTimepoint: every treatment visit | — |
Countries
Brazil, India, Malaysia, Singapore, Viet Nam
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed