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OpenTrials
Completed

NCT Number: NCT07020988

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

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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Key information

Conditions

Healthy Participants

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Up0127 1001

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Staccato alprazolam

Drug

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

Other names: UCB7538

midazolam

Drug

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

Diazepam

Drug

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

Primary outcomes

  1. 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

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

    Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the quantitative electroencephalogram (qEEG) data recorded for each study participant.

  2. 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 iv midazolam in Group 1

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

    Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the quantitative electroencephalogram (qEEG) data recorded for each study participant.

Secondary outcomes

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs) from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)

    Time frame: From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)

    Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.

  2. Occurrence of Serious TEAEs from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)

    Time frame: From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)

    Serious Treatment-Emergent Adverse Events (Serious TEAEs) are any untoward medical incidence in a participant during administered study treatment, whether or not these events are related to study treatment and additionally are emergent untoward medical occurrence that at any dose:

    Results in death; Is life-threatening; Requires in patient hospitalisation or prolongation of existing hospitalisation; Results in persistent disability/incapacity; Is a congenital anomaly or birth defect; Important medical events.

  3. 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 2

    Time frame: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2

    Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the qEEG data recorded for each study participant.

  4. 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 nasal diazepam in Group 2

    Time frame: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2

    Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the qEEG data recorded for each study participant.

  5. Maximum concentration (Cmax) of alprazolam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    Cmax=maximum concentration

  6. Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of alprazolam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    AUC(0-t)=area under the concentration-time curve from time 0 to the last quantifiable concentration

  7. Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of alprazolam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    AUC=area under the concentration-time curve from time 0 to infinity

  8. Maximum concentration (Cmax) of midazolam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    Cmax=maximum concentration

  9. Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of midazolam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    AUC(0-t)=area under the concentration-time curve from time 0 to the last quantifiable concentration

  10. Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of midazolam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    AUC=area under the concentration-time curve from time 0 to infinity

  11. Maximum concentration (Cmax) of diazepam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    Cmax=maximum concentration

  12. Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of diazepam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    AUC(0-t)=area under the concentration-time curve from time 0 to the last quantifiable concentration

  13. Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of diazepam

    Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose

    AUC=area under the concentration-time curve from time 0 to infinity

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

An Open Label, Single Dose, Randomized, Active Comparator, Quantitative Electroencephalogram Crossover Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Intravenous Midazolam and of Staccato Alprazolam Versus Nasal Diazepam in Healthy Study Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Feb 20, 2026

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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