Up0104 1001
Baltimore, Maryland, 21225, United States
NCT Number: NCT05626439
The purpose of the study is to evaluate the relative bioavailability of alprazolam in plasma following a single dose of Staccato alprazolam compared to a single dose of oral alprazolam under fasted conditions
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21225, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A male participant must agree to use contraception as detailed in the protocol during the Treatment Periods and for at least 7 days after the second Investigational Medicinal Product (IMP) administration and must refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Exclusion criteria
Study participants will receive single dose of Staccato alprazolam by inhalation at pre-specified time points.
Other names: UCB7538
Study participants will receive single dose of oral alprazolam at pre-specified time points.
Other names: Xanax
Time frame: Plasma samples will be collected from Baseline (Day 1 predose) at predefined time points (up to Day 3)
AUC = Area under the plasma concentration-time curve from time zero to infinity
Time frame: Plasma samples will be collected from Baseline (Day 1 predose) at predefined time points (up to Day 3)
AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration
Time frame: Plasma samples will be collected from Baseline (Day 1 predose) at predefined time points (up to Day 3)
Cmax = Maximum plasma concentration
Time frame: From Baseline (Day 1) of Treatment Period 1 to the end of Safety Follow-Up (up to 25 days)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
Time frame: From Baseline (Day 1) of Treatment Period 1 to the end of Safety Follow-Up (up to 25 days)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical events referred to in the Protocol.
UCB Biopharma SRL
Industry
An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Evaluate The Relative Bioavailability of Staccato Alprazolam Compared to Oral Alprazolam in Healthy Study Participants
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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