A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of Staccato Alprazolam in Adolescent Study Participants With Epilepsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 8
- 主要终点
- Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 12 to 17 years of age inclusive, at the time of signing the Informed Consent form (ICF) and the Assent form
- •Participant has an established diagnosis of focal, generalized, or focal and generalized epilepsy
- •Participant is in good general health as determined by medical evaluation including medical history and physical examination
- •Participants with a body weight ≥29 kg and body mass index (BMI) within the range 14 to 32 kg/m^2 (inclusive)
- •A male participant must agree to use contraception
- •A female participant is eligible to participate if she is not pregnant
- •Participant is capable of and provides assent, and the study participant's parent/legal representative provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the ICF, Assent form, and in this protocol
- •Participant has a lifetime history of never smoking >5 cigarettes/day, and a current history (for at least 6 months prior to Screening Visit) of not smoking at all (including e-cigarette and vaping products)
- •Participant has forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >80% predicted at Screening. In case of an out-of-range result, 1 repeat test will be allowed. If the readings are out-of-range again, the study participant will be excluded
- •Participant is willing and able to be confined to a clinical research facility for up to 36 hours (including 1 overnight stay) and comply with the study schedule and study requirements.
- •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
- •Participant is currently taking at least 1 background antiepileptic drug (AED)
- •Participant is able to actuate the training device during Screening, according to Instructions for Use
排除标准
- •Participant has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, hematological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of Investigational Medicinal Product (IMP); constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the Investigator
- •Participant has a known hypersensitivity to any components of the IMP or comparative drugs (and/or an investigational device) as stated in the protocol
- •Participant has severe chronic cardio-respiratory disease
- •Participant has history of acute narrow angle glaucoma, hydrocephalus, or Myasthenia Gravis
- •Participant has history or has current airway disease such asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- •Participant has any acute respiratory signs/symptoms (ie, wheezing) and active acute respiratory infection (or within 1 week of dosing) with exception of symptoms of mild rhinitis
- •Participant has a known hypersensitivity to albuterol or similar short-acting beta2-agonist (SABA) that may be used as rescue medication administered in response to potential bronchospasm
- •Participant is taking strong liver inducing agents (eg, phenytoin, phenobarbital, carbamazepine, and primidone) or strong Cytochrome P450 3A4 (CYP3A4) inhibitors
- •Participant has a SpO2 measured by pulse oximetry <95% for >30 seconds during the Screening Visit
研究组 & 干预措施
Staccato alprazolam
The study participants will receive a single dose of Staccato alprazolam.
干预措施: Alprazolam (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam
时间窗: 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.
Cmax = Maximum plasma concentration.
Percentage of participants with serious treatment-emergent adverse event (serious TEAEs)
时间窗: From baseline (Day 1) till end of Safety Follow-up (up to Day 9)
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.
Apparent total body clearance (CL/F) following single inhaled dose of Staccato alprazolam
时间窗: 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.
CL/F = Apparent total body clearance.
Percentage of participants with treatment-emergent adverse event (TEAEs)
时间窗: From baseline (Day 1) till end of Safety Follow-up (up to Day 9)
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.
Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC(0-t)) following single inhaled dose of Staccato alprazolam
时间窗: 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.
AUC(0-t) = Area under the plasma concentration-time curve from zero to the last quantifiable concentration.
Area under the plasma concentration-time curve from time 0 to infinity (AUC) following single inhaled dose of Staccato alprazolam
时间窗: 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.
AUC = Area under the plasma concentration-time curve from time 0 to infinity.
次要结局
未报告次要终点