NCT06006559

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

A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 \[cohort 2\]).

Conditions

• Dengue

Interventions

Type	Name	Description
DRUG	EYU688	EYU688 administered by oral route
DRUG	Placebo	Matching placebo administered orally as capsules

Timeline

• Start date: 2024-02-20
• Primary completion: 2027-01-07
• Completion: 2027-01-15
• First posted: 2023-08-23
• Last updated: 2026-03-24

Locations

23 sites across 6 countries: Brazil, Colombia, India, Malaysia, Singapore, Vietnam