NCT03858075
Completed
Phase 1
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
ConditionsHealthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- BLU-782
- Conditions
- Healthy Volunteers
- Sponsor
- Blueprint Medicines Corporation
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single ascending doses with BLU-782
Intervention: BLU-782
Single ascending doses with placebo
Intervention: Placebo
Multiple ascending doses with BLU-782
Intervention: BLU-782
Multiple ascending doses with placebo
Intervention: Placebo
Food effect of BLU-782 taken with food
Intervention: BLU-782 taken with food
Food effect of BLU-782 taken without food
Intervention: BLU-782
Outcomes
Primary Outcomes
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
Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782.
Time Frame: Baseline to Day 8
Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 .
Time Frame: Baseline to Day 17
Study Sites (1)
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