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-AG-120

Phase 1

Healthy Volunteers | Small molecule | Other |Agios Pharmaceuticals, Inc.|Last Updated: Dec 14, 2015

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
NCT02489513Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120PHASE1 COMPLETED 8Jun 1, 2015Oct 1, 2015Dec 14, 20151 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics - Total [14C] Whole blood and plasma
up to 29 days

Total \[14C\]-radioactivity in whole blood and plasmafollowing oral administration of a single 500-mg (approximately 200 μCi) radiolabeled dose of AG-120 in male subjects

Pharmacokinetics of single dose of AG-120 (Cmax)
up to 29 days

time of maximum observed drug concentration

Pharmacokinetics of single dose of AG-120 (AUC)
up to 29 days

Area under the curve

Pharmacokinetics of single dose of AG-120 (t1/2)
up to 29 days

Estimate of the terminal elimination half-life

Pharmacokinetics - Total [14C] urine and feces
up to 29 days

Total \[14C\]-radioactivity in urine, and feces (and vomitus, if applicable).

Secondary Endpoints
AG120 Metabolite identification
up to 29 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Single group assignmentOTHER\[14C\]-AG-120
Interventions
NameTypeDescription
[14C]-AG-120DRUGLabeled investigational drug
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Is a healthy adult male of any race and aged 18 to 55 years, inclusive, at the time of signing the Informed Consent Form (ICF) 2. Understands and voluntarily signs an ICF before any study-related assessments/procedures are conducted 3. Is willing and able to adhere to the stu...

Countries:United States
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