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BLU-782

Phase 1

Undisclosed | Small molecule | Other |Blueprint Medicines Corporation|Trials Updated: Nov 8, 2019

BLU-782 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 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

BLU-782 clinical trials

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
Healthy VolunteersUnlock trial analytics

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?

BLU-782 is an investigational small molecule developed by Blueprint Medicines Corporation. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been publicly disclosed, and it remains in early clinical development.

Who makes BLU-782?

BLU-782 is being developed by Blueprint Medicines Corporation, which trades on the Nasdaq under the ticker symbol BPMC. The company sponsored the Phase 1 study of BLU-782 conducted in the United States.

What phase is BLU-782 in?

BLU-782 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is BLU-782 in?

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

What was the design of the BLU-782 Phase 1 trial?

The Phase 1 trial NCT03858075 evaluated the safety, tolerability, pharmacokinetics, and food effect of BLU-782 in healthy adults. It enrolled 108 participants aged 19 years and older of all sexes in the United States. The study was randomized, double-blind, and placebo-controlled, and it has been completed.