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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Study participants randomized into this arm will receive single dose of Staccato alprazolam followed by single dose of oral alprazolam at pre-specified time points in the sequence AB. |
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| Treatment Sequence BA | Experimental | Study participants randomized into this arm will receive single dose of oral alprazolam followed by single dose of Staccato alprazolam at pre-specified time points in the sequence BA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staccato alprazolam | Drug | Study participants will receive single dose of Staccato alprazolam by inhalation at pre-specified time points. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 to infinity (AUC) of alprazolam | AUC = Area under the plasma concentration-time curve from time zero to infinity | Plasma samples will be collected from Baseline (Day 1 predose) at predefined time points (up to Day 3) |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of alprazolam | AUC(0-t) = Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration | Plasma samples will be collected from Baseline (Day 1 predose) at predefined time points (up to Day 3) |
| Maximum plasma concentration (Cmax) of alprazolam | Cmax = Maximum plasma concentration | Plasma samples will be collected from Baseline (Day 1 predose) at predefined time points (up to Day 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of study participants with treatment-emergent adverse events (TEAEs) | 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. | From Baseline (Day 1) of Treatment Period 1 to the end of Safety Follow-Up (up to 25 days) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0104 1001 | Baltimore | Maryland | 21225 | United States |
Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Oral alprazolam | Drug | Study participants will receive single dose of oral alprazolam at pre-specified time points. |
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| Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs) | 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. | From Baseline (Day 1) of Treatment Period 1 to the end of Safety Follow-Up (up to 25 days) |
| D006571 | Heterocyclic Compounds |