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

Launched by UCB BIOPHARMA SRL · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare how quickly three different medications—Staccato alprazolam, midazolam, and diazepam—start to work in healthy adults. Researchers will measure brain activity through a special test called a quantitative electroencephalogram (qEEG) to see which medication takes effect the fastest. The study aims to gather important information about these medications, which can help in understanding their use in different medical situations.

To participate in the trial, individuals need to be between 20 and 55 years old and in good health, meaning they should not have any serious medical or mental health issues. Participants will also need to meet specific weight and body mass index (BMI) requirements. Those who join the study will undergo health screenings to ensure their safety. It's important to note that the trial is not yet recruiting participants, so no one can sign up just yet. If you're interested in learning more about this study or think you might qualify, keep an eye out for updates!

Gender

ALL

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.