ReclutandoNCT06006559Registro de ClinicalTrials.gov

A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

Dengue

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - 60 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 108 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever.

Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK \[cohort 1\] and sparse PK sampling \[cohort 2\]).

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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 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 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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

EYU688

EYU688 administered by oral route

Drug: EYU688

Placebo

Matching placebo

Drug: Placebo

EYU688 DRUG

EYU688 administered by oral route

Placebo DRUG

Matching placebo administered orally as capsules

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start

Plazo: From predose to 48 hours post treatment start

Efficacy assessment of EYU688. It will allow to quantify the viremia reduction at 48 hours post treatment start from baseline.

Medidas secundarias

Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃

Plazo: From fever onset to Day 15

Efficacy assessment of EYU688. It will allow to assess the time needed between fever onset and defervescence.

Time from fever onset to the first of two consecutive negative viremia by PCR

Plazo: From fever onset to Day 15

Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15

Area under the log-transformed viremia curve (AUC) from the first dose to Day 15

Plazo: From fever onset to Day 15

Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day 15

Changes of viral load over time

Plazo: From baseline to Day 15

Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15

Incidence and severity of Adverse Events (AEs)

Plazo: From inclusion to Day 15

Incidence and severity of AEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.

Incidence and severity of Serious Adverse Events (SAEs)

Plazo: From inclusion to Day 35

Incidence and severity of SAEs by treatment group

Change of white blood cell count over time from baseline

Plazo: From baseline to Day 15

Assessment of safety and tolerability of EYU688

Change of platelet count over time

Plazo: From baseline to Day 15

Assessment of safety and tolerability of EYU688

Change of hematocrit level and percentage increase from baseline over time

Plazo: From baseline to Day 15

Assessment of safety and tolerability of EYU688

Change of AST, ALT levels over time

Plazo: From baseline to Day 15

Assessment of safety and tolerability of EYU688

No warning signs by day 7 of fever onset

Plazo: From inclusion to Day 15