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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BLU-782; Drug: Placebo; Drug: BLU-782 taken with food

• Registration Number: NCT03858075
• Lead Sponsor: Blueprint Medicines Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-06
• Study Start: 2019-02-12
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single ascending doses with BLU-782	BLU-782	-
Single ascending doses with placebo	Placebo	-
Multiple ascending doses with BLU-782	BLU-782	-
Multiple ascending doses with placebo	Placebo	-
Food effect of BLU-782 taken with food	BLU-782 taken with food	-
Food effect of BLU-782 taken without food	BLU-782	-

Primary Outcome Measures

Name	Time	Method
Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.	Baseline to Day 20
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

Trial Locations

Locations (1)

Undisclosed; 🇺🇸 Lincoln, Nebraska, United States