A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2019-10-16
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Treatments: Ethanol

Criteria

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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.

• 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.