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OpenTrials
Completed

NCT Number: NCT03858075

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

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

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Key information

Conditions

Healthy Volunteers

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Undisclosed

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BLU-782

Drug

oral capsules

Placebo

Drug

oral capsules

BLU-782 taken with food

Drug

oral capsules

Primary outcomes

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

    Time frame: Baseline to Day 8

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

    Time frame: Baseline to Day 17

  3. 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

Sponsors and collaborators

Lead sponsor

Blueprint Medicines Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2019
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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