Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants

A Placebo-Controlled, Double-blind, Randomized Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants

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 Overview

• Status: Completed
• Conditions: Healthy Study Participants
• Intervention / Treatment: Drug: Alprazolam; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Up0101 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staccato alprazolam; Study participants will receive Single dose of Staccato alprazolam on Day 1 of the Treatment Period.	Drug: Alprazolam; Study participants will receive Staccato alprazolam at prespecified time-point.; Other Names: UCB7538
Placebo Comparator: Staccato placebo; Study participants will receive placebo on Day 1 of the Treatment Period.	Other: Placebo; Study participants will receive Staccato placebo at prespecified time-point.; Other Names: PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events refered in the Protocol.	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: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events refered in the Protocol.	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Phase 1; Staccato alprazolam; Alprazolam; STAP-001; Healthy Study Participants
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Alprazolam
• Other Study ID Numbers: UP0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes