CompletedPhase 1

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

United States55 participantsStarted 2025-06-12

Plain-language summary

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).

Who can participate

Age range

20 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 minutes of study intervention administration of Staccato alprazolam in Group 1

Timeframe: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1

Trial details

NCT IDNCT07020988

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-06

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