Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults

Blueprint Medicines

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: BLU-782; Drug: BLU-782 taken with food

Study type: Interventional

Funder types: Industry

Identifiers

NCT03858075

BLU-782-0101

Details and patient eligibility

About

The main objectives of this study are to assess the safety, tolerability, pharmacokinetics (PK), and food effect of BLU-782 in healthy adult subjects.

Enrollment: 108 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 incapacitation or major emotional problems
• History or current clinically significant medical/psychiatric condition/disease
• History of any illness that, in the opinion of the Investigator, might impact the results of the study or pose an additional risk to the participant
• History or current alcoholism/drug abuse
• History or current allergy to the study drug or a similar drug

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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108 participants in 6 patient groups, including a placebo group

Single ascending doses with BLU-782

Experimental group

Treatment:

Drug: BLU-782

Single ascending doses with placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Multiple ascending doses with BLU-782

Experimental group

Treatment:

Drug: BLU-782

Multiple ascending doses with placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Food effect of BLU-782 taken with food

Experimental group

Treatment:

Drug: BLU-782 taken with food

Food effect of BLU-782 taken without food

Experimental group

Treatment:

Drug: BLU-782