Phase
Condition
N/ATreatment
EYU688
Placebo
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, 18 - 60 years old (inclusive).
History or presence of fever (≥ 38°C). At least one of the following criteriaindicating 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
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 considersshould exclude the participants, especially those that require continuation of othermedications 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
- at screening.
Participants with any of the following abnormalities of clinical laboratoryparameters 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 tostomach pH value increase up to 48 hours prior to screening.
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring dosing and for 4 days after stopping of investigational drug.
History or long-QT syndrome, or clinically significant ECG abnormalities, or any ofthe following ECG abnormalities at screening:
QTcF > 450 msec (males)
QTcF > 460 msec (females)
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Manaus, AM 69040-000
BrazilActive - Recruiting
Novartis Investigative Site
Brasilia, DF 71 635-580
BrazilActive - Recruiting
Novartis Investigative Site
Sorocaba, SP 18040-425
BrazilActive - Recruiting
Novartis Investigative Site
Sao Jose do Rio Preto, 15090 000
BrazilActive - Recruiting
Novartis Investigative Site
Sao Jose do Rio Preto, 15090 000
BrazilActive - Recruiting
Novartis Investigative Site
Mumbai, Maharashtra 400008
IndiaActive - Recruiting
Novartis Investigative Site
Pune, Maharashtra 411013
IndiaActive - Recruiting
Novartis Investigative Site
Jaipur, Rajasthan 302017
IndiaActive - Recruiting
Novartis Investigative Site
Chennai, Tamilnadu 600113
IndiaActive - Recruiting
Novartis Investigative Site
Kuantan, Pahang 25200
MalaysiaActive - Recruiting
Novartis Investigative Site
Ipoh, Perak 30450
MalaysiaActive - Recruiting
Novartis Investigative Site
Seberang Jaya, Pulau Pinang 13700
MalaysiaActive - Recruiting
Novartis Investigative Site
Miri, Sarawak 98000
MalaysiaActive - Recruiting
Novartis Investigative Site
Singapore, S308433
SingaporeActive - Recruiting
Novartis Investigative Site
Hanoi, 100000
VietnamActive - Recruiting
Novartis Investigative Site
Ho Chi Minh, 700000
VietnamActive - Recruiting
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