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

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ClinicalTrials.gov Identifier: NCT03858075
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BLU-782 Drug: Placebo Drug: BLU-782 taken with food Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Single ascending doses with BLU-782 Drug: BLU-782
oral capsules

Placebo Comparator: Single ascending doses with placebo Drug: Placebo
oral capsules

Experimental: Multiple ascending doses with BLU-782 Drug: BLU-782
oral capsules

Placebo Comparator: Multiple ascending doses with placebo Drug: Placebo
oral capsules

Experimental: Food effect of BLU-782 taken with food Drug: BLU-782 taken with food
oral capsules

Experimental: Food effect of BLU-782 taken without food Drug: BLU-782
oral capsules




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858075


Contacts
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Contact: Blueprint Medicines 617-714-6707 studydirector@blueprintmedicines.com

Locations
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United States, Nebraska
Undisclosed Recruiting
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Blueprint Medicines Corporation

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Responsible Party: Blueprint Medicines Corporation
ClinicalTrials.gov Identifier: NCT03858075     History of Changes
Other Study ID Numbers: BLU-782-0101
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No