A Study of Balapiravir in Patients With Dengue Virus Infection

Study Overview
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Brief Summary
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This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection

Conditions
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Dengue

Intervention / Treatment
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* Drug: balapiravir [RO4588161]
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male patients, 18-65 years of age dengue virus infection (confirmed by NS1 strip test) with symptom onset </=48 hours before first study drug administration patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiving the last dose of study drug BMI between 18 and 35 Exclusion Criteria: positive test at screening for HIV using point of care test, or known HIV infection history of any disease known to cause significant alteration in immunologic function or autoimmune disease patients taking steroid or other immuno-suppressive therapies positive test for drugs of abuse or alcohol using point of care test clinically significant abnormal laboratory test results which are deemed unassociated with dengue infection or, alternatively, are diagnostic of dengue shock syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: balapiravir [RO4588161]<br>* sequential cohorts receiving doses orally twice daily for 5 days<br>|
| Placebo Comparator: B<br> | Drug: placebo<br>* orally twice daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Adverse events, laboratory parameters, vital signs |  | days 1-7 and on follow-up days 14, 28 and 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load |  | days 1-7 and 14 | 
| Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites |  | multiple sampling days 1 and 5 | 
| Body temperature |  | days 1-7 and on follow-up days 14, 28 and 84 | 
| Immunological parameters: plasma samples (cytokines) |  | days 1-7 and 14 | 
| Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count) |  | days 1-7, and on follow-up days 14, 28 and 84 | 
| Quality of life |  | assessments days 1, 3, 5, 7, 14, 28 and 84 |