Study of BLU-808 in Healthy Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2025-01-21

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Parts 1 and 2 are double-blind and placebo-controlled. Part 3 is open-label.

Study Groups

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Part 1: BLU-808

BLU-808 will be administered orally.

Group Type EXPERIMENTAL

BLU-808

Intervention Type DRUG

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

Part 1: Placebo

Matching placebo for BLU-808 will be administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Part 2: BLU-808

BLU-808 will be administered orally.

Group Type EXPERIMENTAL

BLU-808

Intervention Type DRUG

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

Part 2: Placebo

Matching placebo for BLU-808 will be administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

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

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

Group Type EXPERIMENTAL

BLU-808

Intervention Type DRUG

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

Midazolam

Intervention Type DRUG

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

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Midazolam

Intervention Type DRUG

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

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

BLU-808 will be administered orally.

Group Type EXPERIMENTAL

BLU-808

Intervention Type DRUG

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

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

BLU-808 will be administered orally.

Group Type EXPERIMENTAL

BLU-808

Intervention Type DRUG

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

Interventions

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BLU-808

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes