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The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staccato alprazolam | Experimental | Study participants will receive Single dose of Staccato alprazolam on Day 1 of the Treatment Period. |
|
| Staccato placebo | Placebo Comparator | Study participants will receive placebo on Day 1 of the Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam | Drug | Study participants will receive Staccato alprazolam at prespecified time-point. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Japanese 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. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP). | From Baseline to the end of the Safety-Follow-Up (up to Day 10) |
| Percentage of Japanese study participants with serious adverse event (SAEs) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
| From Baseline to the end of the Safety-Follow-Up (up to Day 10) |
| Percentage of Chinese 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. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP). | From Baseline to the end of the Safety-Follow-Up (up to Day 10) |
| Percentage of Chinese study participants with serious adverse events (SAEs) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of Staccato alprazolam in Caucasian study participants | Cmax = Maximum plasma concentration. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Up0101 101 | Anaheim | California | 92801 | 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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| Placebo | Other | Study participants will receive Staccato placebo at prespecified time-point. |
|
|
| From Baseline to the end of the Safety-Follow-Up (up to Day 10) |
| Maximum plasma concentration (Cmax) of Staccato alprazolam in Japanese study participants | Cmax = Maximum plasma concentration. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Japanese study participants | AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Japanese study participants | AUCinf = Area under the plasma concentration-time curve from time 0 to infinity. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| Maximum plasma concentration (Cmax) of Staccato alprazolam in Chinese study participants | Cmax = Maximum plasma concentration. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Chinese study participants | AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Chinese study participants | AUCinf = Area under the plasma concentration-time curve from time 0 to infinity. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Caucasian study participants | AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Caucasian study participants | AUCinf = Area under the plasma concentration-time curve from time 0 to infinity. | Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose |
| 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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