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OpenTrials
Completed

NCT Number: NCT06948032

Study of BLU-808 in Healthy Adult Participants

This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy adult participants. Part 2 will also include an evaluation of the effect of multiple doses of BLU-808 on the single-dose pharmacokinetics (PK) of midazolam. Part 3 is an open-label, 2-sequence, 2-period, food effect (FE) study in healthy adult participants.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
  • Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, or vital signs, as deemed by the Principal Investigator (PI) or designee.
  • No clinically significant cardiac history as judged by the PI or designee at the screening visit and check-in.

Key Exclusion Criteria:

  • Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • Participant has history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI, designee, or Sponsor.
  • Participant has history or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
  • Participant has positive results at the screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  • Participant has been on a diet incompatible with the on-study diet (that is, unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial), in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
  • Participant has participated in another clinical study within 30 days prior to the first dosing. The 30-day window will be derived from the date of the last dosing in the previous study to the first dosing of the current study.
  • Participant has positive coronavirus disease 2019 (COVID-19) results at first check-in.

Note: Other protocol-specified inclusion and exclusion criteria may apply.

Treatment and study plan

BLU-808

Drug

BLU-808 will be administered per schedule specified in the arm description.

Placebo

Drug

BLU-808 matching placebo will be administered per schedule specified in the arm description.

midazolam

Drug

Midazolam will be administered per schedule specified in the arm description.

Primary outcomes

  1. Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Day 20

  2. Part 2: Number of Participants With TEAEs

    Time frame: Up to Day 50

  3. Part 3: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t)

    Time frame: Up to Day 6

  4. Part 3: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 6

Secondary outcomes

  1. Part 1: AUC0-t

    Time frame: Up to Day 6

  2. Part 1: Cmax

    Time frame: Up to Day 6

  3. Part 1: Terminal Elimination Half-life (t1/2)

    Time frame: Up to Day 6

  4. Part 1: Change From Baseline in QTc (Corrected Value of the Interval Between the Q and T Waves on the Electrocardiogram Tracing)

    Time frame: Up to Day 6

  5. Parts 1 and 2: Change From Baseline in Serum Tryptase Concentrations

    Time frame: Up to Day 6

  6. Part 2: AUC0-t

    Time frame: Up to Day 14

  7. Part 2: Cmax

    Time frame: Up to Day 14

  8. Part 2: t1/2

    Time frame: Up to Day 19

  9. Part 3: Number of Participants With TEAEs

    Time frame: Up to Day 26

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 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLU-808 and to Assess the Drug-Drug Interaction With a CYP3A Substrate (Midazolam) and the Effect of Food in Healthy Adult Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2025
Registry last updated
Apr 28, 2025

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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