Study of BLU-808 in Healthy Adult Participants

NCT06948032 | Completed Phase 1 FDA Drug

• 1 other identifier: BLU-808-0101
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

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

  Up to Day 20

• Part 2: Number of Participants With TEAEs

  Up to Day 50

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

  Up to Day 6

• Part 3: Maximum Observed Plasma Concentration (Cmax)

  Up to Day 6

Secondary Outcomes (9)

• Part 1: AUC0-t

  Up to Day 6

• Part 1: Cmax

  Up to Day 6

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

  Up to Day 6

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

  Up to Day 6

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

  Up to Day 6

Study Arms (8)

Part 1: BLU-808

EXPERIMENTAL

BLU-808 will be administered orally.

Drug: BLU-808

Part 1: Placebo

PLACEBO COMPARATOR

Matching placebo for BLU-808 will be administered orally.

Drug: Placebo

Part 2: BLU-808

EXPERIMENTAL

BLU-808 will be administered orally.

Drug: BLU-808

Part 2: Placebo

PLACEBO COMPARATOR

Matching placebo for BLU-808 will be administered orally.

Drug: Placebo

Part 2: Midazolam Alone Followed by BLU-808 and Midazolam

EXPERIMENTAL

Participants will receive oral midazolam in Period 1. Participants will then receive oral BLU-808 with midazolam in period 2.

Drug: BLU-808; Drug: Midazolam

Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam

PLACEBO COMPARATOR

Participants will receive oral midazolam in Period 1. Participants will then receive oral matching placebo for BLU-808 with midazolam in period 2.

Drug: Placebo; Drug: Midazolam

Part 3: BLU-808 (Treatment D, E)

EXPERIMENTAL

BLU-808 will be administered orally.

Drug: BLU-808

Part 3: BLU-808 (Treatment E, D)

EXPERIMENTAL

BLU-808 will be administered orally.

Drug: BLU-808

Interventions

BLU-808 DRUG

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

Part 1: BLU-808; Part 2: BLU-808; Part 2: Midazolam Alone Followed by BLU-808 and Midazolam; Part 3: BLU-808 (Treatment D, E); Part 3: BLU-808 (Treatment E, D)

Placebo DRUG

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

Part 1: Placebo; Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam; Part 2: Placebo

Midazolam DRUG

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

Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and Midazolam; Part 2: Midazolam Alone Followed by BLU-808 and Midazolam

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blueprint Medicines Corporation: lead

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parts 1 and 2 are double-blind and placebo-controlled. Part 3 is open-label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 28, 2025
• Study Start: August 7, 2024
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: April 28, 2025

Record last verified: 2025-04

Locations

US (1)