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Clinical Trials/NCT01797419
NCT01797419
Withdrawn
Phase 1

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Ranging Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5806 in Subjects < 24 Months of Age Hospitalized for Respiratory Syncytial Virus (RSV) Related Respiratory Infection

Gilead Sciences9 sites in 1 countryMay 2013
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ConditionsRespiratory Syncytial Virus Infections
InterventionsGS-5806Placebo
DrugsGS-5806Placebo

Overview

Phase
Phase 1
Intervention
GS-5806
Conditions
Respiratory Syncytial Virus Infections
Sponsor
Gilead Sciences
Locations
9
Primary Endpoint
Safety and tolerability
Status
Withdrawn
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •\<24 months of age
  • •Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening

Exclusion Criteria

  • •Chronic or congenital heart disease
  • •Required ventilation or admission to any pediatric Intensive Care Unit
  • •Inadequate organ function

Arms & Interventions

GS-5806

Single dose, oral liquid, .5 mL/kg

Intervention: GS-5806

Placebo

Single dose, oral liquid, .5 mL/kg

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability

Time Frame: 10 days from subject randomization to study drug

Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.

Secondary Outcomes

  • Pharmacokinetics effects of GS-5806(10 days from subject randomization to study drug)

Study Sites (9)

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