Recent Updates
Recently added Catalysts

BLU-782

Phase 1

Healthy Volunteers | Small molecule | Other |Blueprint Medicines Corporation|Last Updated: Nov 8, 2019

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03858075Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy AdultsPHASE1 COMPLETED 108 — — Feb 12, 2019Sep 11, 2019Nov 8, 20191 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782.
Baseline to Day 8
Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 .
Baseline to Day 17
Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.
Baseline to Day 20
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Single ascending doses with BLU-782EXPERIMENTAL -
Single ascending doses with placeboPLACEBO_COMPARATOR -
Multiple ascending doses with BLU-782EXPERIMENTAL -
Multiple ascending doses with placeboPLACEBO_COMPARATOR -
Food effect of BLU-782 taken with foodEXPERIMENTAL -
Food effect of BLU-782 taken without foodEXPERIMENTAL -
Interventions
NameTypeDescription
BLU-782DRUGoral capsules
PlaceboDRUGoral capsules
BLU-782 taken with foodDRUGoral capsules
Unlock Study Design Details
Eligibility Criteria
Age Range19 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Medically healthy * Non-smoker * Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 * No clinically significant cardiac history * No current electrocardiogram (ECG) abnormality * Female must not be of childbearing potential Exclusion Criteria: * History of or current mental or legal ...

Countries:United States
Unlock Eligibility Criteria