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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Dengue

Treatments: Drug: EYU688; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06006559

CEYU688A12201

Details and patient eligibility

About

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.

Full description

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]).

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

EYU688

Experimental group

Description:

EYU688 administered by oral route

Treatment:

Drug: EYU688

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo