A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy 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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-12

Study Completion Date

2026-01-29

Brief Summary

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The purpose of this study is to estimate the difference in the time to onset of action between Staccato alprazolam and intravenous (iv) midazolam using changes in power in the combined spindle and β1 frequency bands in the qEEG (quantitative electroencephalogram).

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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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Main Part-Group 1: Treatment Sequence AB

Study participants randomized in Group 1 will receive Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 1 followed by Treatment B: IV Midazolam on Day 1 of the Intervention Period 2.

Group Type EXPERIMENTAL

Staccato Alprazolam

Intervention Type DRUG

Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.

Midazolam

Intervention Type DRUG

Study participants will receive single dose of IV Midazolam at pre-specified time points.

Main Part-Group 1: Treatment Sequence BA

Study participants randomized in Group 1 will receive Treatment B: IV Midazolam on Day 1 of the Intervention Period 1 followed by Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 2.

Group Type EXPERIMENTAL

Staccato Alprazolam

Intervention Type DRUG

Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.

Midazolam

Intervention Type DRUG

Study participants will receive single dose of IV Midazolam at pre-specified time points.

Main Part-Group 2: Treatment Sequence AC

Study participants randomized in Group 2 will receive Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 1 followed by Treatment C: Nasal Diazepam on Day 1 of the Intervention Period 2.

Group Type EXPERIMENTAL

Staccato Alprazolam

Intervention Type DRUG

Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.

Diazepam

Intervention Type DRUG

Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.

Main Part-Group 2: Treatment Sequence CA

Study participants randomized in Group 2 will receive Treatment C: Nasal Diazepam on Day 1 of the Intervention Period 1 followed by Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 2.

Group Type EXPERIMENTAL

Staccato Alprazolam

Intervention Type DRUG

Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.

Diazepam

Intervention Type DRUG

Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.

Pilot Part

Study participants who successfully completed the Screening Period will receive single dose of Intravenous (IV) midazolam on Day 1 of the Intervention Period.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Study participants will receive single dose of IV Midazolam at pre-specified time points.

Interventions

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Staccato Alprazolam

Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.

Intervention Type DRUG

Midazolam

Study participants will receive single dose of IV Midazolam at pre-specified time points.

Intervention Type DRUG

Diazepam

Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.

Intervention Type DRUG

Other Intervention Names

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UCB7538

Eligibility Criteria

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Inclusion Criteria

* Participant must be 20 years to 55 years of age, inclusive, at the time of signing the ICF.
* Participant is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring, at the Screening Visit and on Day -1 of the single Intervention Period for the Pilot Part or on Day -1 of the first Intervention Period for the Main Part of the study.
* Participant has a bodyweight of at least 45 kilograms (kg) (female) and 50 kg (male) and a body mass index within the range of 18 Kilograms per meter square (Kg/m2) to 30 kg/m2 (inclusive)
* Participant has given informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.

Exclusion Criteria

* Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study.
* Participant has a history of chronic alcohol or drug abuse, as defined in the most recent version of the Diagnostic and Statistical Manual of Mental Disorders, within 6 months prior to the Screening Visit.
* Participant has a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* Participant has a history of or has been diagnosed with epilepsy or epileptic seizures.
* Participant has abnormal EEG findings at Screening including background slowing (\<8Hz), focal slowing (focal δ-activity), or epileptiform discharges.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes