Clinical trial NCT04782388: Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
Official title: A Placebo-Controlled, Double-blind, Randomized Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Study Participants
Keywords: Healthy Study Participants
Phase 1
Staccato alprazolam
Alprazolam
STAP-001
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.


Eligibility criteria: Inclusion Criteria:

* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF)
* Participants are overtly healthy as determined by medical evaluation including medical history and physical examination
* For Japanese: Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Japanese grandparents born in Japan) For Chinese: Participant is of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China)
* Participant has a body weight (BW) of at least 45 kg (female) and 50 kg (male) and body mass index (BMI) within the range 18 to 30 kg/m\^2(inclusive)

Exclusion Criteria:

* Participant has any medical or psychiatric condition that, in the opinion of the Investigator,could jeopardize or would compromise the study participant's ability to participate in this study
* Participant has a history or present condition of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders (eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction) 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
* Participant has abnormal blood pressure (BP). Study participants must have BP and heart rate (HR) within normal range in the supine position after 5 minutes rest (systolic blood pressure (SBP): 90 mmHg to 140 mmHg, diastolic blood pressure (DBP): 50 mmHg to 90 mmHg, HR: 50 bpm to 100 bpm). Any values marginally (ie, no more than 5mmHg) outside the normal range but considered not clinically significant by the Investigator would be allowed. In case of an out-of-range result, 1 repeat will be allowed. If the readings are out of range again, the study participant will not be included
* Participant has a current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders V, within the previous 6 months
* Participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
* Participant has history of or current clinical signs/symptoms consistent with suspected and/or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/coronavirus disease 2019 (COVID-19) (eg, fever, persistent cough, shortness of breath, fatigue, loss or change to senses of smell or taste)

Primary outcomes:
measure: Percentage of Japanese study participants with treatment-emergent adverse events (TEAEs)
timeFrame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
measure: Percentage of Japanese study participants with serious adverse event (SAEs)
timeFrame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
measure: Percentage of Chinese study participants with treatment-emergent adverse events (TEAEs)
timeFrame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
measure: Percentage of Chinese study participants with serious adverse events (SAEs)
timeFrame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
measure: Maximum plasma concentration (Cmax) of Staccato alprazolam in Japanese study participants
timeFrame: 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
measure: Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Japanese study participants
timeFrame: 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
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Japanese study participants
timeFrame: 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
measure: Maximum plasma concentration (Cmax) of Staccato alprazolam in Chinese study participants
timeFrame: 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
measure: Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Chinese study participants
timeFrame: 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
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Chinese study participants
timeFrame: 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
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of Staccato alprazolam in Caucasian study participants
timeFrame: 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
measure: Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast) of Staccato alprazolam in Caucasian study participants
timeFrame: 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
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Staccato alprazolam in Caucasian study participants
timeFrame: 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
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Up0101 101
state: California
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: