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AG881

Phase 1

Healthy Volunteers | Small molecule | Other |Agios Pharmaceuticals, Inc.|Last Updated: Apr 2, 2020

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04145128A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian ParticipantsPHASE1 COMPLETED 32 — — Oct 2, 2019Dec 18, 2019Apr 2, 20201 United States
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Study Endpoints
Primary Endpoints
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC0-last) of AG881
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) of AG881
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Clearance Following Extravascular Dosing (CL/F) of AG881
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Plasma Concentration Observed (Cmax) of AG881
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t1/2) of AG881
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time of Maximum Plasma Concentration (tmax) of AG881
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution (Vd/F) of AG881
Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Secondary Endpoints
Number of Participants with Changes in Clinical Laboratory Tests from Screening to 22 days in Period 1 and 2
Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Physical Examinations from Screening to 22 days in Period 1 and 2
Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Vital Sign Measurements from Screening to 22 days in Period 1 and 2
Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
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Study Design & Arms
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AG-881EXPERIMENTALParticipants will receive AG-881 10 mg, tablet orally, once in Period 1 followed by AG-881 50 mg, tablet orally, once in Period 2. Period 1 and Period 2 will be separated by a washout period of 20 days between doses.
Interventions
NameTypeDescription
AG881DRUGAG-881 tablets.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Have provided voluntary written informed consent. 2. Adult male or female, 18 to 55 years of age, inclusive, at Screening. 3. Continuous nonsmoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study. 4. Have a...

Countries:United States
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