The purpose of this study is to assess the potential for pharmacokinetic (PK) and pharmacodynamics (PD) interactions between ASP8062 and alcohol. This study will also assess safety and tolerability of a single dose of ASP8062 with or without alcohol.
Participants will be admitted to the clinical unit on day -1 of each period and will be residential for 6 days/5 nights. Participants will be discharged from the clinical unit on day 5 of each period on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit. Participants will return to the clinical unit on days 7 and 10 for pharmacokinetic blood sampling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
Parexel International - EPCU Baltimore
Baltimore, Maryland, United States
Pharmacokinetics (PK) of ASP8062 in plasma: area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time frame: Up to Day 10 of each treatment period
Pharmacokinetics (PK) of ASP8062 in plasma: maximum concentration (Cmax)
Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time frame: Up to Day 10 of each treatment period
Pharmacokinetics (PK) of alcohol in Ethanol plasma: AUClast
AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time frame: Day 1 of each treatment period
Pharmacokinetics (PK) of alcohol in Ethanol plasma: Cmax
Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time frame: Day 1 of each treatment period
Change from baseline in reaction times defined by Cogstate battery: psychomotor function
The psychomotor function domain will be assessed using the Detection Test. Participants will tap a moving target on a grid and reaction times will be recorded. Change from baseline will be reported at indicated time points. Lower scores mean better performance.
Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
Change from baseline in reaction times defined by Cogstate battery: attention
The attention domain will be assessed using the Identification Test. Participants will answer "yes" or "no" to the question "is the card red or not?" and reaction times will be recorded. Change from baseline will be reported at indicated time points. Lower scores mean better performance.
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Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
Change from baseline in reaction times defined by Cogstate battery: working memory
The working memory domain will be assessed using the One Back Test. Participants will answer "yes" or "no" to the question "is the previous card the same?" and reaction times will be recorded. Change from baseline will be reported at indicated time points. Lower scores mean better performance.
Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
Change from baseline in number of error attempts defined by Cogstate battery: executive function
The executive function domain will be assessed using the Groton Maze Learning Test. Participants will be asked to find a hidden pathway and the total number of errors made while attempting to learn the same pathway will be recorded. Change from baseline will be reported at indicated time points. Lower scores mean better performance.
Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
Postural stability test assessed via the single-leg stance test
Limb dominance will be determined and recorded prior to performing the single leg stance test. Time will commence when eyes are closed and end for any of the following reasons: participant uses arms; participant uses the raised foot; participant moves the weight bearing foot to maintain balance; a maximum of 45 seconds has elapsed; or participant opens eyes. The test will be repeated 3 times and each time will be recorded. The best and the average of the 3 trials will also be recorded.
Time frame: Day 1 of each treatment period
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an Investigational Product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Time frame: Up to 55 Days (End of Study)
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 55 Days (End of Study)
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 55 Days (End of Study)
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Time frame: Up to 55 Days (End of Study)
Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported.
Time frame: Day 1 of each treatment period
Number of participants with Blood oxygen saturation (SpO2) level abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant SpO2 values.
Time frame: Day 1 of each treatment period