Recent Updates
Recently added Catalysts

AG120

Phase 1

Healthy | Small molecule | Other |Agios Pharmaceuticals, Inc.|Last Updated: Jun 27, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02831972Drug-Drug Interaction Study of AG120 in Healthy SubjectsPHASE1 COMPLETED 22 — — Jun 1, 2016Oct 1, 2016Jun 27, 20171 United States
NCT02579707Food Effect Study of AG120 in Healthy SubjectsPHASE1 COMPLETED 36 — — Oct 1, 2015Jun 1, 2016Nov 29, 20161 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
AG120 Area Under the Curve [AUC]
Period 2: itraconazole administered once daily (QD) for 18 consecutive days (Days -4 to 14) with a single oral dose of AG-120 coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21 days)
AG120 Maximum Plasma Concentration [Cmax]
Period 2: itraconazole administered once daily (QD) for 18 consecutive days (Days -4 to 14) with a single oral dose of AG-120 coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21 days)
Itraconazole Area Under the Curve [AUC]
Period 2: itraconazole administered once daily (QD) for 18 consecutive days (Days -4 to 14) with a single oral dose of AG-120 coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21 days)
Itraconazole Maximum Plasma Concentration [CMAX]
Period 2: itraconazole administered once daily (QD) for 18 consecutive days (Days -4 to 14) with a single oral dose of AG-120 coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21 days)
Cmax
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.

Maximum observed concentration of AG-120

Incidence of adverse events
22 days

Assessment of adverse events

Tmax
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.

Time of maximum concentration of AG-120

AUC0-t
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.

Area under the concentration-time curve from Hour 0 to the last measurable concentration

AUC0-infinity
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.

Area under the concentration-time curve extrapolated to infinity

t1/2
Day 1 predose (for each period as applicable) (0 hour [approximately 45 minutes prior to dose]) and 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 48, 72, 120, 168, 240, 336, and 504 hours post dose.

Apparent terminal elimination half-life

Secondary Endpoints
Hydroxy-itraconazole Area Under the Curve [AUC]
Period 2: Day -2 up to Day 13
Hydroxy-itraconazole Maximum Plasma Concentration [CMAX]
Period 2: Day -2 up to Day 13
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Period 1EXPERIMENTALA single oral dose of AG-120 will be administered at Hour 0 followed by PK sampling for 504 hours (21 days).
Period 2EXPERIMENTALIn Period 2, multiple oral doses of itraconazole will be administered once daily (QD) for 18 consecutive days (Days -4 to 14) with a single oral dose of AG-120 coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21 days) following AG-120 dosing on Day 1. PK sampling will also be collected for itraconazole and its metabolite, hydroxy-itraconazole, from Day -2 up to Day 13.
Treatment A: UnfedACTIVE_COMPARATORTreatment A: Single oral dose of AG-120 at Hour 0 on Day 1, following a 10-hour overnight fast.
Treatment B: FedACTIVE_COMPARATORTreatment B: Single oral dose of AG-120 at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast.
Part 2 Single DoseEXPERIMENTALPART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120.
Interventions
NameTypeDescription
AG120DRUG -
ItraconazoleDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy, adult, male or female, 18 - 55 years of age, inclusive, at screening. 2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study. 3. BMI ≥ 18.5 and ≤ 32.0 kg/m2 at screening. 4. Medica...

Countries:United States
Unlock Eligibility Criteria