Actively Recruiting
A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of EYU688 in Adults With Dengue Fever
Led by Novartis Pharmaceuticals · Updated on 2026-03-24
108
Participants Needed
23
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of EYU688, an oral medication, compared with a placebo in patients with dengue fever. The study aims to understand how EYU688 affects dengue viral load, fever clearance time, and clinical signs and symptoms. This randomized, participant- and investigator-blinded, placebo-controlled trial includes two parallel groups with different pharmacokinetic sampling schedules. Participants will receive either EYU688 or a matching placebo capsule orally. The study consists of two cohorts running at the same time with intensive pharmacokinetic sampling in one and sparse sampling in the other. The research evaluates safety, efficacy, and pharmacokinetic properties of EYU688 over a treatment period. During the study, participants will undergo assessments including viral load measurement, fever monitoring, laboratory tests for blood counts and liver enzymes, and evaluation of dengue severity signs. Safety will be monitored through adverse event tracking up to 35 days. The primary outcome focuses on viral load reduction 48 hours after treatment starts, with secondary outcomes covering fever duration, clinical recovery, and other health indicators up to 15 days post-fever onset.
CONDITIONS
Brief Title
A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 60 years inclusive
- History or presence of fever of 38�C or higher
- At least one symptom indicating dengue infection such as nausea, vomiting, rash, headache, muscle or joint pain
- Fever started 48 hours or less before treatment begins
- Positive test confirming dengue fever
You will not qualify if you...
- Abnormal clinical laboratory parameters
- Use of anticoagulant drugs
- Significant medical conditions or illnesses requiring medications that may interact with the study drug
- Pregnant or nursing (lactating) women
- Severe dengue symptoms at screening per WHO guidelines
- Low hemoglobin levels (less than 12.0 g/dL in males, less than 11.0 g/dL in females)
- High hematocrit levels (over 52% in males, over 46% in females)
- Low neutrophil count (less than 1500/bcL)
- Low platelet count (less than 80,000/mm3)
- High creatinine levels (over 165 bcmol/L in males, over 130 bcmol/L in females)
- High serum creatine kinase (over 600 U/L)
- Elevated liver enzymes ALT or AST more than 1.5 times the upper normal limit
- High total bilirubin (over 24 bcmol/L)
- Use of proton pump inhibitors within 48 hours before screening
- Women of child-bearing potential not using highly effective contraception during dosing and for 4 days after stopping study drug
- History or current long-QT syndrome or significant ECG abnormalities
- QTcF interval over 450 msec for males or over 460 msec for females
- Other protocol-defined criteria as applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days
Participants receive oral doses of EYU688 or placebo to treat dengue fever.
Daily visits or assessments during treatment
Duration - Up to 20 days after treatment
Participants are monitored for safety and clinical outcomes after treatment ends.
Visits up to Day 35 for safety monitoring
Trial Site Locations
Total: 23 locations
1
Novartis Investigative Site
Manaus, Amazonas, Brazil, 69040-000
Actively Recruiting
2
Novartis Investigative Site
Brasília, Federal District, Brazil, 71635-580
Actively Recruiting
3
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360
Actively Recruiting
4
Novartis Investigative Site
Sorocaba, São Paulo, Brazil, 18040-425
Actively Recruiting
5
Novartis Investigative Site
Sao Jose Rio Preto, Brazil, 15090 000
Actively Recruiting
6
Novartis Investigative Site
Barranquilla, Atlántico, Colombia, 080012
Actively Recruiting
7
Novartis Investigative Site
Bucaramanga, Santander Department, Colombia, 681017
Actively Recruiting
8
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
9
Novartis Investigative Site
Belagavi, Karnataka, India, 590010
Actively Recruiting
10
Novartis Investigative Site
Mumbai, Maharashtra, India, 400008
Withdrawn
11
Novartis Investigative Site
Pune, Maharashtra, India, 411013
Actively Recruiting
12
Novartis Investigative Site
Jaipur, Rajasthan, India, 302017
Actively Recruiting
13
Novartis Investigative Site
Chennai, Tamil Nadu, India, 600113
Actively Recruiting
14
Novartis Investigative Site
Kuantan, Pahang, Malaysia, 25200
Actively Recruiting
15
Novartis Investigative Site
Ipoh, Perak, Malaysia, 30450
Actively Recruiting
16
Novartis Investigative Site
Seberang Jaya, Pulau Pinang, Malaysia, 13700
Actively Recruiting
17
Novartis Investigative Site
Miri, Sarawak, Malaysia, 98000
Actively Recruiting
18
Novartis Investigative Site
Kuala Selangor, Malaysia, 68000
Actively Recruiting
19
Novartis Investigative Site
Singapore, Singapore, 169608
Actively Recruiting
20
Novartis Investigative Site
Singapore, Singapore, S308433
Actively Recruiting
21
Novartis Investigative Site
Haiphong, Vietnam, 180000
Actively Recruiting
22
Novartis Investigative Site
Hanoi, Vietnam, 100000
Actively Recruiting
23
Novartis Investigative Site
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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