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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858075
• Other study ID #: BLU-782-0101
• Status: Completed
• Phase: Phase 1
• Start date: February 12, 2019
• Est. completion date: September 11, 2019

Study information

• Verified date: October 2019
• Source: Blueprint Medicines Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BLU-782
oral capsules
• Placebo
oral capsules
• BLU-782 taken with food
oral capsules

Locations

Country	Name	City	State
United States	Undisclosed	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Blueprint Medicines Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782.		Baseline to Day 8
Primary	Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 .		Baseline to Day 17
Primary	Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.		Baseline to Day 20