Healthy VolunteersPhase 1NCT04003402
A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
A Phase 1 study testing ASP8062 and Alcohol in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ASP8062 and Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 16 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and female subjects (21 to 55 years of age, inclusive) who currently consume alcohol regularly but do not meet the diagnostic and statistical manual of mental disorders (DSM-5) criteria for alcohol use disorders and are able to consume 3 to 4 standard drinks at 1 occasion without causing excessive intoxication.
- Subject currently consumes alcohol regularly but does not meet the diagnostic and statistical manual of mental disorders (DSM-5) criteria for alcohol use disorders and subject is able to consume 3 to 4 standard drinks at 1 occasion without causing excessive intoxication. (note: standard drink =1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor).
- Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after final investigational product (IP) administration.
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- Female subject must agree not to breastfeed starting at screening and throughout the study period and for 28 days after final IP administration.
- Female subject must not donate ova starting at first dose of IP and throughout the study period and for 28 days after final IP administration.
- Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception, throughout the treatment period and for 90 days after final IP administration.
- Male subject must not donate sperm during the treatment period and for 90 days after final IP administration.
- Male subject with a pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 90 days after final IP administration.
- Subject agrees to not participate in another interventional study while participating in the present study.
Who cannot join
- Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP8062, alcohol or any components of the formulations used.
- Subject has had previous exposure with ASP8062.
- Subject has any of the liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase and total bilirubin [TBL]) above 1.5 × upper limit of normal (ULN) on day -1 of period 1. In such a case, the assessment may be repeated once.
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- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first IP administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
- Subject has a current, untreated moderate or severe mental illness as assessed by the Mini International Neuropsychiatric Interview (MINI).
- Subject has a relevant history of suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 12 months or subject who is at significant risk to commit suicide using the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening and on day -1 of period 1.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
- Subject has any clinically significant abnormality following the investigator's review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1.
- Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure (SBP) > 140 mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after subject has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- Subject has a mean QT interval using Fridericia's correction formula (QTcF) of > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
- Subject has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to first IP administration, except for occasional use of paracetamol (up to 2 g/day), topical dermatological products, including corticosteroid products, hormonal contraceptives and hormone replacement therapy (HRT).
- Subject has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening or the subject tests positive for cotinine at screening.
- Subject has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening or the subject tests positive for alcohol at screening or on day -1 of period 1.
- Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the subject tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on day -1 of period 1.
- Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
- Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
- Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin M), hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
- Subject is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International - EPCU Baltimore
Baltimore, Maryland, 21225
About this study
Official title: A Phase 1 Randomized, Placebo-controlled, Crossover Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- ASP8062, Alcohol, ASP8062 Placebo, Alcohol Placebo
- Keywords
- alcohol effect, Healthy Volunteer, ASP8062
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8062Drug
oral
AlcoholDrug
Also called ethanol
oral
ASP8062 PlaceboDrug
oral
Alcohol PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Participants receiving treatment sequence A,B,C,D | Experimental | Eligible participants will received treatment sequence A, B, C, D. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration.
A= ASP8062 with Alcohol; B= ASP8062 with Placebo Alcohol; C= Placebo ASP8062 with Alcohol; D = Placebo ASP8062 with Placebo Alcohol Receives: Drug: ASP8062; Drug: Alcohol; Drug: ASP8062 Placebo; Drug: Alcohol Placebo |
| Sequence 2: Participants receiving treatment sequence B,D,A,C | Experimental | Eligible participants will received treatment sequence B, D, A, C. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration.
B= ASP8062 with Placebo Alcohol; D = Placebo ASP8062 with Placebo Alcohol; A= ASP8062 with Alcohol; C= Placebo ASP8062 with Alcohol Receives: Drug: ASP8062; Drug: Alcohol; Drug: ASP8062 Placebo; Drug: Alcohol Placebo |
| Sequence 3: Participants receiving treatment sequence C,A,D,B | Experimental | Eligible participants will received treatment sequence C, A, D, B. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration.
C= Placebo ASP8062 with Alcohol; A= ASP8062 with Alcohol; D = Placebo ASP8062 with Placebo Alcohol; B= ASP8062 with Placebo Alcohol Receives: Drug: ASP8062; Drug: Alcohol; Drug: ASP8062 Placebo; Drug: Alcohol Placebo |
| Sequence 4: Participants receiving treatment sequence D,C,B,A | Experimental | Eligible participants will received treatment sequence D, C, B, A. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration.
D = Placebo ASP8062 with Placebo Alcohol; C= Placebo ASP8062 with Alcohol; B= ASP8062 with Placebo Alcohol; A= ASP8062 with Alcohol Receives: Drug: ASP8062; Drug: Alcohol; Drug: ASP8062 Placebo; Drug: Alcohol Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 of each treatment period
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start16 Jul 2019
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003402
- Sponsor's protocol ID
- 8062-CL-2001
- Status last verified
- Oct 2024
- First submitted
- 27 Jun 2019
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Placebo-controlled, Crossover Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04003402
- Acronym / sponsor ID
- 8062-CL-2001
- Conditions
- Healthy Volunteers
- Keywords
- alcohol effect, Healthy Volunteer, ASP8062
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Participants receiving treatment sequence A,B,C,D | Experimental | Drug: ASP8062, Drug: Alcohol, Drug: ASP8062 Placebo, Drug: Alcohol PlaceboEligible participants will received treatment sequence A, B, C, D. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration. A= ASP8062 with Alcohol; B= ASP8062 with Placebo Alcohol; C= Placebo ASP8062 with Alcohol; D = Placebo ASP8062 with Placebo Alcohol |
| Sequence 2: Participants receiving treatment sequence B,D,A,C | Experimental | Drug: ASP8062, Drug: Alcohol, Drug: ASP8062 Placebo, Drug: Alcohol PlaceboEligible participants will received treatment sequence B, D, A, C. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration. B= ASP8062 with Placebo Alcohol; D = Placebo ASP8062 with Placebo Alcohol; A= ASP8062 with Alcohol; C= Placebo ASP8062 with Alcohol |
| Sequence 3: Participants receiving treatment sequence C,A,D,B | Experimental | Drug: ASP8062, Drug: Alcohol, Drug: ASP8062 Placebo, Drug: Alcohol PlaceboEligible participants will received treatment sequence C, A, D, B. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration. C= Placebo ASP8062 with Alcohol; A= ASP8062 with Alcohol; D = Placebo ASP8062 with Placebo Alcohol; B= ASP8062 with Placebo Alcohol |
| Sequence 4: Participants receiving treatment sequence D,C,B,A | Experimental | Drug: ASP8062, Drug: Alcohol, Drug: ASP8062 Placebo, Drug: Alcohol PlaceboEligible participants will received treatment sequence D, C, B, A. Each participant will receive a single oral dose and each treatment period has a minimum of a 14 day washout period between investigational product administration. D = Placebo ASP8062 with Placebo Alcohol; C= Placebo ASP8062 with Alcohol; B= ASP8062 with Placebo Alcohol; A= ASP8062 with Alcohol |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adult male and female subjects (21 to 55 years of age, inclusive) who currently consume alcohol regularly but do not meet the diagnostic and statistical manual of mental disorders (DSM-5) criteria for alcohol use disorders and are able to consume 3 to 4 standard drinks at 1 occasion without causing excessive intoxication.
- Subject currently consumes alcohol regularly but does not meet the diagnostic and statistical manual of mental disorders (DSM-5) criteria for alcohol use disorders and subject is able to consume 3 to 4 standard drinks at 1 occasion without causing excessive intoxication. (note: standard drink =1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor).
- Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Female subject must agree not to breastfeed starting at screening and throughout the study period and for 28 days after final IP administration.
Key exclusion criteria (22 listed)
- Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP8062, alcohol or any components of the formulations used.
- Subject has had previous exposure with ASP8062.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8062oral | Drug | Sequence 1: Participants receiving treatment sequence A,B,C,D, Sequence 2: Participants receiving treatment sequence B,D,A,C, Sequence 3: Participants receiving treatment sequence C,A,D,B, Sequence 4: Participants receiving treatment sequence D,C,B,A |
| AlcoholAlso: ethanoloral | Drug | Sequence 1: Participants receiving treatment sequence A,B,C,D, Sequence 2: Participants receiving treatment sequence B,D,A,C, Sequence 3: Participants receiving treatment sequence C,A,D,B, Sequence 4: Participants receiving treatment sequence D,C,B,A |
| ASP8062 Placebooral | Drug | Sequence 1: Participants receiving treatment sequence A,B,C,D, Sequence 2: Participants receiving treatment sequence B,D,A,C, Sequence 3: Participants receiving treatment sequence C,A,D,B, Sequence 4: Participants receiving treatment sequence D,C,B,A |
| Alcohol Placebooral | Drug | Sequence 1: Participants receiving treatment sequence A,B,C,D, Sequence 2: Participants receiving treatment sequence B,D,A,C, Sequence 3: Participants receiving treatment sequence C,A,D,B, Sequence 4: Participants receiving treatment sequence D,C,B,A |
Primary outcome
Pharmacokinetics (PK) of ASP8062 in plasma: area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to Day 10 of each treatment period
AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of ASP8062 in plasma: maximum concentration (Cmax)
Time frame: Up to Day 10 of each treatment period
Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of alcohol in Ethanol plasma: AUClast
Time frame: Day 1 of each treatment period
AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.
Pharmacokinetics (PK) of alcohol in Ethanol plasma: Cmax
Time frame: Day 1 of each treatment period
Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Change from baseline in reaction times defined by Cogstate battery: psychomotor function
Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
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.
Change from baseline in reaction times defined by Cogstate battery: attention
Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
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.
Change from baseline in reaction times defined by Cogstate battery: working memory
Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
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.
Change from baseline in number of error attempts defined by Cogstate battery: executive function
Time frame: Baseline and Day 1 of each treatment period (90 minutes, 2.5 hours, 4 hours and 6 hours post dose)
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.
Postural stability test assessed via the single-leg stance test
Time frame: Day 1 of each treatment period
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.
6 secondary outcomes
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
Time frame: Up to 55 Days (End of Study)
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: Up to 55 Days (End of Study)
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Time frame: Up to 55 Days (End of Study)
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
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)
Time frame: Day 1 of each treatment period
Number of participants with Blood oxygen saturation (SpO2) level abnormalities and/or Adverse Events (AEs)
Time frame: Day 1 of each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP8062 and Alcohol in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of ASP8062 in plasma: area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) (time frame: Up to Day 10 of each treatment period). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.