A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

• Status: Completed
• Trial end date: 2020-09-11
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine.

This study also assessed the potential for pharmacokinetic interaction between ASP8062 and morphine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Morphine

Criteria

Inclusion Criteria:

• Participant is a recreational opioid user who has used opioids for nontherapeutic (recreational) purposes on at least 10 occasions within their lifetime, with at least 1 opioid use in the last 90 days.

• Participant has a body mass index (BMI) range of 18 to 36 kg/m^2, inclusive and weighs at least 50 kg at screening.

• Female participant 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 participant must agree not to breastfeed starting at screening and throughout the study period and for 28 days after final IP administration.

• Female participant must not donate ova starting at first dose of IP and throughout the study period and for 28 days after final IP administration.

• Male participant 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 participant must not donate sperm during the treatment period and for 90 days after final IP administration.

• Male participant with a pregnant partner(s) must agree to remain abstinent or use a condom with spermicide for the duration of the pregnancy throughout the study period and for 90 days after final IP administration.

• Participant agrees to not participate in another interventional study while participating in the present study.

Exclusion Criteria:

• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.

• Participant has any condition which makes the participant unsuitable for study participation.

• Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.

• Participant has a known or suspected hypersensitivity to ASP8062 or morphine and/or other opioids, or any components of the formulations used.

• Participant has had previous exposure with ASP8062.

• Participant has any of the liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.

• Participant has any clinically significant history of allergic conditions (including drug allergies, asthma or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first IP administration.

• Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal and/or other major disease or malignancy with exception of history of cholecystectomy.

• Participant has a history of moderate or severe use disorder for any substance other than caffeine or tobacco (based on the Diagnostic and Statistical Manual of Mental Disorders, edition 5 (DSM-5) criteria).

• Participant has a history or presence of any clinically significant psychiatric disorders such as, bipolar 1, schizophrenia, schizoaffective disorder or major depressive disorders.

• Participant has had recent suicidal ideation within the last 12 months or participant who is at significant risk to commit suicide using the Baseline/Screening Columbia-suicide severity rating scale (C-SSRS) at screening and the Since Last Visit C-SSRS on day -1.

• Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.

• Participant has any clinically significant abnormality following an investigator's review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1.

• Participant has a mean pulse < 50 or > 90 bpm; mean systolic blood pressure > 150 mmHg; mean diastolic blood pressure > 95 mmHg (measurements taken in duplicate after participant has been resting in the supine position for at least 5 minutes) on day -1. If the mean blood pressure exceeds the limits above, 1 additional duplicate may be taken.

• Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of > 450 msec (for male participants) and > 470 msec (for female participants) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.

• Participant has a positive test for amphetamines, barbiturates, benzodiazepines, cocaine, phencyclidine, alcohol and/or opiates on day -1. Positive tetrahydrocannabinol is not exclusionary and a cannabis intoxication evaluation will be performed. Participant may be reconsidered.

• Participant 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 acetaminophen (up to 2 g/day), topical dermatological products, including corticosteroid products, hormonal contraceptives and hormone replacement therapy (HRT).

• Participant must be willing to abstain from smoking (including use of tobacco-containing products and nicotine or nicotine-containing products [e.g., electronic vapes]) from at least 1 hour predose through at least 8 hours postdose on days 9 and 10.

• Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.

• Participant has had significant blood loss, donated approximately 500 mL of whole blood (excluding plasma donation) within 56 days prior to screening or donated plasma within 7 days prior to day -1.

• Participant has a positive serology test for hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.

• Participant has loss of ability to freely provide consent through imprisonment or involuntary incarceration for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

• Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.