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
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Feb 2019
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2019
CompletedStudy Start
First participant enrolled
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2019
CompletedNovember 8, 2019
October 1, 2019
7 months
February 6, 2019
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (6)
Single ascending doses with BLU-782
EXPERIMENTALSingle ascending doses with placebo
PLACEBO COMPARATORMultiple ascending doses with BLU-782
EXPERIMENTALMultiple ascending doses with placebo
PLACEBO COMPARATORFood effect of BLU-782 taken with food
EXPERIMENTALFood effect of BLU-782 taken without food
EXPERIMENTALInterventions
oral capsules
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Undisclosed
Lincoln, Nebraska, 68502, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2019
First Posted
February 28, 2019
Study Start
February 12, 2019
Primary Completion
September 11, 2019
Study Completion
September 11, 2019
Last Updated
November 8, 2019
Record last verified: 2019-10