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BLU-782

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

BLU-782 · 1 trial · 1 indication

Phase 1 1
NCT03858075Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy AdultsHealthy Volunteers
COMPLETED108 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults
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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
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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
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Eligibility Criteria

Age Range19 Years to 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
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Frequently asked questions about BLU-782

What is BLU-782 used for?

BLU-782 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is currently in Phase 1 clinical development. The only completed trial evaluated its safety, tolerability, pharmacokinetics, and food effect in healthy adults.

Who makes BLU-782?

BLU-782 is being developed by Blueprint Medicines Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol BPMC. The company conducted a Phase 1 trial of BLU-782 in healthy volunteers in the United States.

What phase is BLU-782 in?

BLU-782 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial, NCT03858075, has been completed.

What clinical trials is BLU-782 in?

BLU-782 has one completed clinical trial, NCT03858075, titled "Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults." This Phase 1 study enrolled 108 healthy volunteers in the United States and was placebo-controlled and double-blind.

Is BLU-782 FDA approved?

BLU-782 is not FDA approved. It is an investigational small molecule that has completed a Phase 1 trial in healthy volunteers. Its safety and efficacy have not been established for any medical condition, and it remains in clinical development.