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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BLU-782 When Administered Orally to Healthy Adult Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03858075
Enrollment
108
Registered
2019-02-28
Start date
2019-02-12
Completion date
2019-09-11
Last updated
2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGBLU-782

oral capsules

DRUGPlacebo

oral capsules

DRUGBLU-782 taken with food

oral capsules

Sponsors

Blueprint Medicines Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026