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

• Status: Completed
• Trial end date: 2021-04-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Biopharma SRL
• Treatments: Alprazolam

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)