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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
* Pharmaceutical form: Inhalation powder. * Study participants will receive Staccato alprazolam at prespecified time-points.
Up0100 102
Little Rock, Arkansas, United States
Up0100 110
Orlando, Florida, United States
Up0100 103
Honolulu, Hawaii, United States
Up0100 101
Bethesda, Maryland, United States
Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam
Cmax = Maximum plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Up0100 108
Rochester, New York, United States
Up0100 106
Cincinnati, Ohio, United States
Up0100 105
Memphis, Tennessee, United States
Up0100 107
Tacoma, Washington, United States
Time frame: 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.
Time frame: From baseline (Day 1) till end of Safety Follow-up (up to Day 9)