Healthy
Conditions
Keywords
Healthy Volunteer, Abuse Liability, ALKS 5461, Alkermes
Brief summary
This study will evaluate the abuse potential of ALKS 5461.
Interventions
DRUGALKS 5461
Sublingual tablets, single administration
DRUGBuprenorphine
Sublingual tablets, single administration
DRUGPlacebo
Sublingual tablets, single administration
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg * Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime * Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal * Be willing and able to abide by all study requirements and restrictions * Additional criteria may apply
Exclusion criteria
* Have evidence of drug or alcohol dependence within the past 2 years * Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic * Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting * Be currently pregnant, breastfeeding, or planning to become pregnant during the study * Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone) * Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) * Have donated or lost more than 500 mL whole blood * Additional criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: Abuse potential measured by visual analog scales (VAS) | Approximately 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events (AEs) | Up to 14 weeks |
| Pharmacokinetics: Plasma concentrations of ALKS 5461 | Up to 14 weeks |
Countries
United States
Outcome results
None listed