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

Blueprint Medicines Corporation108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

108

Conditions

Healthy Volunteers

Interventions

BLU-782DRUG

oral capsules

PlaceboDRUG

oral capsules

BLU-782 taken with foodDRUG

oral capsules

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Undisclosed

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782.

Time frame: Baseline to Day 8

Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 .

Time frame: Baseline to Day 17

Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.

Time frame: Baseline to Day 20

Data from ClinicalTrials.gov

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