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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: BLU-782; Drug: BLU-782 taken with food

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Undisclosed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single ascending doses with BLU-782	Drug: BLU-782; oral capsules
PLACEBO_COMPARATOR: Single ascending doses with placebo	Drug: Placebo; oral capsules
EXPERIMENTAL: Multiple ascending doses with BLU-782	Drug: BLU-782; oral capsules
PLACEBO_COMPARATOR: Multiple ascending doses with placebo	Drug: Placebo; oral capsules
EXPERIMENTAL: Food effect of BLU-782 taken with food	Drug: BLU-782 taken with food; oral capsules
EXPERIMENTAL: Food effect of BLU-782 taken without food	Drug: BLU-782; oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Blueprint Medicines Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2019
• Primary Completion (ACTUAL): September 11, 2019
• Study Completion (ACTUAL): September 11, 2019

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (ACTUAL): February 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: BLU-782-0101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No