Healthy Participants
Conditions
Keywords
Phase 1, Staccato alprazolam, midazolam, diazepam, Healthy Study Participants
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).
Interventions
Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.
DRUGMidazolam
Study participants will receive single dose of IV Midazolam at pre-specified time points.
DRUGDiazepam
Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) | 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. |
| Occurrence of Serious TEAEs from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) | 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. |
| 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 | 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. |
| 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 | 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. |
| Maximum concentration (Cmax) of alprazolam | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose | Cmax=maximum concentration |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of alprazolam | 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 |
| Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of alprazolam | 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 |
| Maximum concentration (Cmax) of midazolam | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose | Cmax=maximum concentration |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of midazolam | 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 |
| Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of midazolam | 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 |
| Maximum concentration (Cmax) of diazepam | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose | Cmax=maximum concentration |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of diazepam | 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 |
| Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of diazepam | 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 |
Countries
United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273
Outcome results
None listed