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Tests treatment safety and results for Dengue
Official title A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
ClinicalTrials.gov ID: NCT06006559
What this study is testing
What is EYU688?
EYU688 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for dengue.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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:
See the full eligibility 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.
- 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...
- 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 3 X 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Manaus, Amazonas, Brazil
- Brasília, Federal District, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
- Rio Grande, Rio Grande do Sul, Brazil
- Sorocaba, São Paulo, Brazil
- Sao Jose Rio Preto, Brazil
- Barranquilla, Atlántico, Colombia
- Bucaramanga, Santander Department, Colombia
- Cali, Valle del Cauca Department, Colombia
- Belagavi, Karnataka, India
- Mumbai, Maharashtra, India
- Pune, Maharashtra, India
- Jaipur, Rajasthan, India
- Chennai, Tamil Nadu, India
- Kuantan, Pahang, Malaysia
- Ipoh, Perak, Malaysia
- Seberang Jaya, Pulau Pinang, Malaysia
- Miri, Sarawak, Malaysia
- Kuala Selangor, Malaysia
- Singapore, Singapore, Singapore
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manaus, Amazonas, Brazil; Brasília, Federal District, Brazil; Rio de Janeiro, Rio de Janeiro, Brazil; Rio Grande, Rio Grande do Sul, Brazil; Sorocaba, São Paulo, Brazil; Sao Jose Rio Preto, Brazil and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.