The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
30
Study participants will receive Staccato alprazolam at prespecified time-point.
Study participants will receive Staccato placebo at prespecified time-point.
Up0101 101
Anaheim, California, United States
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).
Time frame: 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: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Important medical events refered in the Protocol.
Time frame: 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).
Time frame: 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: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Important medical events refered in the Protocol.
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
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Maximum plasma concentration (Cmax) of Staccato alprazolam in Japanese study participants
Cmax = Maximum plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 Caucasian study participants
Cmax = Maximum plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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