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AG881 Formulation 1

Phase 1

Healthy Volunteers | Small molecule | Other |Agios Pharmaceuticals, Inc.|Last Updated: Jul 21, 2021

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04128787A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881PHASE1 COMPLETED 36 — — Sep 30, 2019Dec 18, 2019Jul 21, 20211 United States
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Study Endpoints
Primary Endpoints
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t½) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t½) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 1 without Food
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Secondary Endpoints
Number of Participants with Abnormalities in Triplicate 12-lead Electrocardiograms (ECGs)
Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Abnormalities in Vital Sign Measurements
Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Columbia-suicide Severity Rating Scale (C-SSRS) Score
Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Sequence ABCDEXPERIMENTALParticipants will receive Treatment A (AG-881 Formulation 1, 50 mg, tablet orally, under fasted condition once on Day 1 of Period 1) followed by Treatment B (AG-881 Formulation 2, 50 mg, tablet orally, under fasted condition once on Day 1 of Period 2) followed by Treatment C (AG-881 Formulation 2, 50 mg, tablet, orally, under fed condition once on Day 1 of Period 3) followed by Treatment D (omeprazole 40 mg capsule, orally, once daily on Days 1 to 4 and AG-881 Formulation 2, 50 mg, tablet, orally, under fasted condition, once on Day 4 of Period 4). Each period will be separated by a Washout Period of 21 days.
Treatment Sequence BCADEXPERIMENTALParticipants will receive Treatment B in Period 1 followed by Treatment C in Period 2 then Treatment A in Period 3 followed by Treatment D in Period 4. Each period will be separated by a Washout Period of 21 days.
Treatment Sequence CABDEXPERIMENTALParticipants will receive Treatment C in Period 1 followed by Treatment A in Period 2 then Treatment B in Period 3 followed by Treatment D in Period 4. Each period will be separated by a Washout Period of 21 days.
Interventions
NameTypeDescription
AG881 Formulation 1DRUGAG881 uncoated tablets
AG881 Formulation 2DRUGAG881 film-coated tablets
OmeprazoleDRUGOmeprazole capsules
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy, adult, male or female (WONCBP) participants, 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 dosing and throughout the study. 3. Body mass index (BMI) ≥ 18.0 ...

Countries:United States
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