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GS-5806

Phase 1

RSV Infection | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jun 10, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01801293A Phase 1 Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of GS-5806PHASE1 COMPLETED 8Mar 1, 2013Apr 1, 2013Jun 10, 20131 United States
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Study Endpoints
Primary Endpoints
Urine and fecal recovery of total [14C]-radioactivity
22 days

The primary outcome measure of this study is the urine and fecal recovery of total \[14C\]-radioactivity.

Secondary Endpoints
Recovery of [14C]-GS-5806
22 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intervention ArmEXPERIMENTALOne-time single dose of 50 mg radiolabeled GS-5806 administered orally in 3 capsules in the morning.
Interventions
NameTypeDescription
GS-5806DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have a calculated body mass index (BMI) from 19 to 30 kg/m2 at study screening. * In the opinion of the Investigator, subjects must be in good health based upon medical history, physical examination (including vital signs), and screening and baseline laboratory evaluations (he...

Countries:United States
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