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The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staccato alprazolam | Experimental | The study participants will receive a single dose of Staccato alprazolam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam | Cmax = Maximum plasma concentration. | Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. |
| Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC(0-t)) following single inhaled dose of Staccato alprazolam | AUC(0-t) = Area under the plasma concentration-time curve from zero to the last quantifiable concentration. | Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC) following single inhaled dose of Staccato alprazolam | AUC = Area under the plasma concentration-time curve from time 0 to infinity. | Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. |
| Apparent total body clearance (CL/F) following single inhaled dose of Staccato alprazolam | CL/F = Apparent total body clearance. | Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. |
| Percentage of participants with treatment-emergent adverse event (TEAEs) |
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Inclusion Criteria:
Note: If there are no clinical contraindications, as per Investigator's judgment, study participants may leave the clinical research facility after the 6-hour postdose assessments and return to the clinic on Day 2 for the 24-hour and 36-hour postdose assessments
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 |
|---|---|---|---|---|---|---|
| Up0100 102 | Little Rock | Arkansas | 72205 | United States | ||
| Up0100 110 |
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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An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant temporally associated with the use of IMP, whether or not considered related to the IMP.
| From baseline (Day 1) till end of Safety Follow-up (up to Day 9) |
| Percentage of participants with serious treatment-emergent adverse event (serious TEAEs) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: a. Results in death c. Requires inpatient hospitalization or prolongation of existing hospitalization d. Results in persistent disability/incapacity e. Is a congenital anomaly/birth defect f. Important medical events. | From baseline (Day 1) till end of Safety Follow-up (up to Day 9) |
| Orlando |
| Florida |
| 32806 |
| United States |
| Up0100 103 | Honolulu | Hawaii | 96817 | United States |
| Up0100 101 | Bethesda | Maryland | 20817 | United States |
| Up0100 108 | Rochester | New York | 14642 | United States |
| Up0100 106 | Cincinnati | Ohio | 45229 | United States |
| Up0100 105 | Memphis | Tennessee | 38103 | United States |
| Up0100 107 | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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