Clinical trial NCT07020988: A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Phase 1
Staccato alprazolam
midazolam
diazepam
Healthy Study Participants
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
timeFrame: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1
Secondary outcomes:
measure: Occurrence of Treatment Emergent Adverse Events (TEAEs) from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)
timeFrame: From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)
measure: Occurrence of Serious TEAEs from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)
timeFrame: From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)
measure: 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
timeFrame: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2
measure: 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
timeFrame: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2
measure: Maximum concentration (Cmax) of alprazolam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of alprazolam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of alprazolam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Maximum concentration (Cmax) of midazolam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of midazolam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of midazolam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Maximum concentration (Cmax) of diazepam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of diazepam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
measure: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of diazepam
timeFrame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: