RecruitingPhase 2NCT06006559

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


Sponsor

Novartis Pharmaceuticals

Enrollment

108 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 Criteria19

  • 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)

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Interventions

DRUGEYU688

EYU688 administered by oral route

DRUGPlacebo

Matching placebo administered orally as capsules


Locations(23)

Novartis Investigative Site

Manaus, Amazonas, Brazil

Novartis Investigative Site

Brasília, Federal District, Brazil

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Novartis Investigative Site

Sorocaba, São Paulo, Brazil

Novartis Investigative Site

Sao Jose Rio Preto, Brazil

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Belagavi, Karnataka, India

Novartis Investigative Site

Mumbai, Maharashtra, India

Novartis Investigative Site

Pune, Maharashtra, India

Novartis Investigative Site

Jaipur, Rajasthan, India

Novartis Investigative Site

Chennai, Tamil Nadu, India

Novartis Investigative Site

Kuantan, Pahang, Malaysia

Novartis Investigative Site

Ipoh, Perak, Malaysia

Novartis Investigative Site

Seberang Jaya, Pulau Pinang, Malaysia

Novartis Investigative Site

Miri, Sarawak, Malaysia

Novartis Investigative Site

Kuala Selangor, Malaysia

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Haiphong, Vietnam

Novartis Investigative Site

Hanoi, Vietnam

Novartis Investigative Site

Ho Chi Minh City, Vietnam

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